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    Also known as: 596-51-0, Glycopyrrolate bromide, Robinul, Glycopyrronium bromide, Gastrodyn, Nodapton
    Molecular Formula
    C19H28BrNO3
    Molecular Weight
    398.3  g/mol
    InChI Key
    VPNYRYCIDCJBOM-UHFFFAOYSA-M
    Glycopyrronium Bromide
    A muscarinic antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics.
    1 2D Structure

    Glycopyrronium Bromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate;bromide
    2.1.2 InChI
    InChI=1S/C19H28NO3.BrH/c1-20(2)13-12-17(14-20)23-18(21)19(22,16-10-6-7-11-16)15-8-4-3-5-9-15;/h3-5,8-9,16-17,22H,6-7,10-14H2,1-2H3;1H/q+1;/p-1
    2.1.3 InChI Key
    VPNYRYCIDCJBOM-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    C[N+]1(CCC(C1)OC(=O)C(C2CCCC2)(C3=CC=CC=C3)O)C.[Br-]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Bromide, Glycopyrronium

    2. Glycopyrronium

    3. Glycopyrronium Bromide

    4. Nva 237

    5. Nva-237

    6. Nva237

    7. Pyrrolidinium, 3-((cyclopentylhydroxyphenylacetyl)oxy)-1,1-dimethyl-, Bromide

    2.2.2 Depositor-Supplied Synonyms

    1. 596-51-0

    2. Glycopyrrolate Bromide

    3. Robinul

    4. Glycopyrronium Bromide

    5. Gastrodyn

    6. Nodapton

    7. Tarodyl

    8. Tarodyn

    9. Asecryl

    10. Cuvposa

    11. Glycopyrronii Bromidum

    12. Robanul

    13. Ahr-504

    14. Bromuro De Glicopirronio

    15. Bromure De Glycopyrronium

    16. Nva-237

    17. Robinal

    18. Seebri Neohaler

    19. 3-hydroxy-1,1-dimethylpyrrolidinium Bromide Alpha-cyclopentylmandelate

    20. Seebri

    21. 1,1-dimethyl-3-hydroxypyrrolidinium Bromide Alpha-cyclopentylmandelate

    22. 1-methyl-3-pyrrolidyl Alpha-phenylcyclopentaneglycolate Methobromide

    23. 3-(2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium Bromide

    24. Pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-,bromide

    25. Ad-237

    26. Pt-001

    27. Nsc-250836

    28. Nsc-251251

    29. Nsc-251252

    30. Copyrrolate

    31. Dsstox_cid_3109

    32. 3-(2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidinium Bromide

    33. (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate Bromide

    34. Dsstox_rid_76878

    35. Dsstox_gsid_23109

    36. Glycopyrronium (bromide);glycopyrrolate (bromide)

    37. Nva237

    38. Robinul Forte

    39. Pyrrolidinium,1-dimethyl-, Bromide

    40. Seebri Breezhaler

    41. 53808-86-9

    42. (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate;bromide

    43. Smr000469282

    44. Glycopyrrolate, Erythro-

    45. Nsc 250836

    46. Nsc 251251

    47. Nsc 251252

    48. Org-nc-45

    49. Nsc250836

    50. Nsc251251

    51. Nsc251252

    52. (2s,3's)-glycopyrrolate

    53. Ahr 504

    54. Glycopyrronium (as Bromide)

    55. Nva 237

    56. Glycopyrronii Bromidum [inn-latin]

    57. Ncgc00179456-02

    58. Wln: T5ktj A1 A1 Covxqr&- Al5tj &q &e

    59. Einecs 209-887-0

    60. Mfcd00072137

    61. Bromure De Glycopyrronium [inn-french]

    62. Bromuro De Glicopirronio [inn-spanish]

    63. Chf5259

    64. Glycopyrrolate [usan:usp]

    65. Pt001

    66. Chf-5259

    67. Lonhala Magnair

    68. Pyrrolidinium,1-dimethyl-, Bromide, .alpha.-cyclopentylmandelate

    69. 1,1-dimethyl-3-hydroxypyrrolidinium Bromide .alpha.-cyclopentylmandelate

    70. 1-methyl-3-pyrrolidinyl .alpha.-phenylcyclopentaneglycolate Methobromide

    71. 3-hydroxy-1,1-dimethylpyrrolidinium Bromide-.alpha.-cyclopentylmandelate

    72. Mandelic Acid, Ester With 3-hydroxy-1,1-dimethylpyrrolidinium Bromide

    73. Cuvposa (tn)

    74. Robinul (tn)

    75. Glycopyrrolate (usp)

    76. .beta.-1-methyl-3-pyrrolidyl-.alpha.-cyclopentylmandelate Methobromide

    77. Seebri Breezhaler (tn)

    78. Cas-596-51-0

    79. Glycopyrrone Bromide

    80. Schembl41436

    81. Glycopyrronium Bromide ,(s)

    82. Mls001424112

    83. Mls002222301

    84. 3-hydroxy-1,1-dimethylpyrrolidinium Bromide .alpha.-cyclopentylmandelate

    85. Chembl1201027

    86. Dtxsid6023109

    87. Chebi:90972

    88. Glycopyrrolate, >=98% (hplc)

    89. Glycopyrronium Bromide (jan/inn)

    90. Hms1570e14

    91. Hms2051p12

    92. Hms2094a05

    93. Hms2097e14

    94. Hms2235f12

    95. Hms3259p04

    96. Hms3369f10

    97. Hms3393p12

    98. Hms3714e14

    99. Hms3885p14

    100. Pharmakon1600-01505753

    101. Amy22352

    102. Bcp07110

    103. Bcp33298

    104. Chf-5992

    105. Ex-a4155

    106. Tox21_113144

    107. Tox21_113145

    108. Nsc759238

    109. S4660

    110. Akos015962136

    111. Pyrrolidinium, 1,1-dimethyl-3-hydroxy-, Bromide, Alpha-cyclopentylmandelate

    112. Pyrrolidinium, 3-hydroxy-1,1-dimethyl-, Bromide, Alpha-cyclopentylmandelate

    113. Tox21_113144_1

    114. Ccg-101030

    115. Ccg-213543

    116. Cs-1763

    117. Nc00280

    118. Nc00694

    119. Nsc-759238

    120. Ncgc00179456-04

    121. Ac-23382

    122. Hy-17465

    123. Glycopyrrolate Erythro Isomer (ss-isomer)

    124. Ft-0626787

    125. G0392

    126. D00540

    127. A832400

    128. Sr-01000763650

    129. Sr-01000763650-3

    130. Q27162963

    131. Glycopyrrolate Erythro Isomer (mixture Of Rr-isomer And Ss-isomer)

    132. Glycopyrrolate, United States Pharmacopeia (usp) Reference Standard

    133. Glycopyrronium Bromide, European Pharmacopoeia (ep) Reference Standard

    134. Glycopyrronium Impurity N, European Pharmacopoeia (ep) Reference Standard

    135. 3-(2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-iumbromide

    136. 3-{[cyclopentyl(hydroxy)phenylacetyl]oxy}-1,1-dimethylpyrrolidin-1-ium Bromide

    137. Glycopyrronium For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    2.3 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 398.3 g/mol
    Molecular Formula C19H28BrNO3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count5
    Exact Mass397.12526 g/mol
    Monoisotopic Mass397.12526 g/mol
    Topological Polar Surface Area46.5 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity424
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameCuvposa
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelCUVPOSA is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is...
    Active IngredientGlycopyrrolate
    Dosage FormSolution
    RouteOral
    Strength1mg/5ml
    Market StatusPrescription
    CompanyMerz Pharms

    2 of 8  
    Drug NameGlycopyrrolate
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelGlycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name:3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. Its empirical fo...
    Active IngredientGlycopyrrolate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1mg; 0.2mg/ml; 1.5mg; 2mg
    Market StatusPrescription
    CompanyStason Pharms; Vintage Pharms; Ranbaxy; Aurolife Pharma; Excellium; Hikma Farmaceutica; Par Pharm; Vintage; Luitpold; Dr Reddys Labs; Nexgen Pharma

    3 of 8  
    Drug NameRobinul
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelROBINUL (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q.s.Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium...
    Active IngredientGlycopyrrolate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1mg; 0.2mg/ml
    Market StatusPrescription
    CompanyShionogi; Hikma Maple

    4 of 8  
    Drug NameRobinul forte
    PubMed HealthGlycopyrrolate (By mouth)
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelRobinul and Robinul Forte tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide...
    Active IngredientGlycopyrrolate
    Dosage FormTablet
    RouteOral
    Strength2mg
    Market StatusPrescription
    CompanyShionogi

    5 of 8  
    Drug NameCuvposa
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelCUVPOSA is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is...
    Active IngredientGlycopyrrolate
    Dosage FormSolution
    RouteOral
    Strength1mg/5ml
    Market StatusPrescription
    CompanyMerz Pharms

    6 of 8  
    Drug NameGlycopyrrolate
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelGlycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name:3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. Its empirical fo...
    Active IngredientGlycopyrrolate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1mg; 0.2mg/ml; 1.5mg; 2mg
    Market StatusPrescription
    CompanyStason Pharms; Vintage Pharms; Ranbaxy; Aurolife Pharma; Excellium; Hikma Farmaceutica; Par Pharm; Vintage; Luitpold; Dr Reddys Labs; Nexgen Pharma

    7 of 8  
    Drug NameRobinul
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelROBINUL (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q.s.Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium...
    Active IngredientGlycopyrrolate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1mg; 0.2mg/ml
    Market StatusPrescription
    CompanyShionogi; Hikma Maple

    8 of 8  
    Drug NameRobinul forte
    PubMed HealthGlycopyrrolate (By mouth)
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelRobinul and Robinul Forte tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide...
    Active IngredientGlycopyrrolate
    Dosage FormTablet
    RouteOral
    Strength2mg
    Market StatusPrescription
    CompanyShionogi

    4.2 Drug Indication

    Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

    Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

    Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

    Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.

    Treatment of sialorrhoea

    Chronic obstructive pulmonary disease

    Treatment of sialorrhoea

    Treatment of hyperhidrosis

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Muscarinic Antagonists

    Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

    Adjuvants, Anesthesia

    Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cholinergic Antagonists [MoA]; Anticholinergic [EPC]
    5.3 ATC Code

    R03BB06

    R03BB06

    R03BB06

    A03AB02

    A03AB02

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    A - Alimentary tract and metabolism

    A03 - Drugs for functional gastrointestinal disorders

    A03A - Drugs for functional gastrointestinal disorders

    A03AB - Synthetic anticholinergics, quaternary ammonium compounds

    A03AB02 - Glycopyrronium bromide

    R - Respiratory system

    R03 - Drugs for obstructive airway diseases

    R03B - Other drugs for obstructive airway diseases, inhalants

    R03BB - Anticholinergics

    R03BB06 - Glycopyrronium bromide

    API Reference Price

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P-60M) (GLYCOPYRROLATE (GLYCOPYRRONIUM BROMIDE)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.12","actualQuantity":"0.12","unit":"KGS","unitRateFc":"176000","totalValueFC":"24090.7","currency":"EUR","unitRateINR":"16499999.9","date":"27-Jul-2023","totalValueINR":"1980000.183","totalValueInUsd":"24090.7","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702665000,"product":"GLYCOPYRROLATE ORAL BATCH NO 23011105","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"PCAS","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"14.35","actualQuantity":"14.35","unit":"KGS","unitRateFc":"17000","totalValueFC":"247047.2","currency":"USD","unitRateINR":"1433100","date":"16-Dec-2023","totalValueINR":"20564985","totalValueInUsd":"247047.2","indian_port":"Madras Air","hs_no":"29339990","bill_no":"9264510","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"MESSUKENTKTU 820210 TURKUSDNF FINLAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711045800,"product":"GLYCOPYRRONIUM BROMIDE MICRONIZED (BATCH NO. 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MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"176000","totalValueFC":"3895.8","currency":"EUR","unitRateINR":"16174400","date":"22-Mar-2024","totalValueINR":"323488","totalValueInUsd":"3895.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"2696035","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGATC\/ARGENT 1, 08755 CASTELLBISBALBARCELONA,SPAIN ES","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715279400,"product":"GLYCOPYRRONIUM BROMIDE MICRONIZED (BATCH NO.P-57M) (GLYCOPYRROLATE (GLYCOPYRRONIUM BROMIDE)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. 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    12-Jan-2021
    27-Sep-2024
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    Drugs in Development

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    QVM149 Receives Regulatory Approval in Europe and Japan

    Details:

    QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.


    Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Novartis Pharmaceuticals Corporation

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 07, 2020

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    01

    Vectura Ltd

    United Kingdom
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    Not Confirmed
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    Lead Product(s) : Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    QVM149 Receives Regulatory Approval in Europe and Japan

    Details : QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.

    Brand Name : Enerzair Breezhaler

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 07, 2020

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    Virtual Booth

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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Gets USFDA Nod for Generic Glycopyrrolate Oral Solution

    Details:

    Cuvposa is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling.


    Lead Product(s): Glycopyrronium Bromide

    Therapeutic Area: Neurology Brand Name: Cuvposa-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 20, 2024

    Granules India

    02

    Granules India Limited

    India
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    CPhI India 2024
    Attending
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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Lead Product(s) : Glycopyrronium Bromide

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules India Gets USFDA Nod for Generic Glycopyrrolate Oral Solution

    Details : Cuvposa is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling.

    Brand Name : Cuvposa-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 20, 2024

    Granules India

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    Lupin Launches World’s First Fixed-dose Triple Combination Drug, Vilfuro-G® for COPD Management in India

    Details:

    Vilfuro-G (vilanterol, fluticasone furoate & glycopyrronium bromide) is world's first fixed-dose triple combination drug which is approved for the treatment of chronic obstructive pulmonary disease (COPD).


    Lead Product(s): Vilanterol Trifenatate,Fluticasone Furoate,Glycopyrronium Bromide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Vilfuro-G

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 23, 2023

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    03

    Lupin Ltd

    India
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    SupplySide West 2024
    Not Confirmed

    Lupin Ltd

    India
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    SupplySide West 2024
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Vilanterol Trifenatate,Fluticasone Furoate,Glycopyrronium Bromide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Launches World’s First Fixed-dose Triple Combination Drug, Vilfuro-G® for COPD Management...

    Details : Vilfuro-G (vilanterol, fluticasone furoate & glycopyrronium bromide) is world's first fixed-dose triple combination drug which is approved for the treatment of chronic obstructive pulmonary disease (COPD).

    Brand Name : Vilfuro-G

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 23, 2023

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    Zydus Healthcare Gets CDSCO Panel Nod to Market Vilanterol, Glycopyrrolate, Fluticasone Metered Dose Inhaler

    Details:

    A fixed dose combination of vilanterol (adrenergic receptor beta-2 agonist), glycopyrrolate & fluticasone furoate is approved for the treatment of chronic obstructive pulmonary disease.


    Lead Product(s): Vilanterol Trifenatate,Glycopyrronium Bromide,Fluticasone Furoate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 13, 2023

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    04

    Zydus Healthcare

    India
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    SupplySide West 2024
    Not Confirmed

    Zydus Healthcare

    India
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    SupplySide West 2024
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Vilanterol Trifenatate,Glycopyrronium Bromide,Fluticasone Furoate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Zydus Healthcare Gets CDSCO Panel Nod to Market Vilanterol, Glycopyrrolate, Fluticasone Metered Do...

    Details : A fixed dose combination of vilanterol (adrenergic receptor beta-2 agonist), glycopyrrolate & fluticasone furoate is approved for the treatment of chronic obstructive pulmonary disease.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 13, 2023

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    Endo Launches PREVDUO (neostigmine methylsulfate and glycopyrrolate injection), the First and Only FDA-Approved Neostigmine-Glycopyrrolate Combination P...

    Details:

    PREVDUO (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe, the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S for Neuromuscular blockade.


    Lead Product(s): Neostigmine Methylsulfate,Glycopyrronium Bromide

    Therapeutic Area: Neurology Brand Name: Prevduo

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 12, 2023

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    Endo International

    Ireland
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    Not Confirmed

    Endo International

    Ireland
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    Not Confirmed
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    Lead Product(s) : Neostigmine Methylsulfate,Glycopyrronium Bromide

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Endo Launches PREVDUO (neostigmine methylsulfate and glycopyrrolate injection), the First and Only...

    Details : PREVDUO (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe, the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S for Neuromuscular blockade.

    Brand Name : Prevduo

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 12, 2023

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    Lupin Receives Approval From USFDA For Glycopyrrolate Injection USP

    Details:

    Glycopyrrolate is an anticholinergic agents, competitively inhibit binding of the neurotransmitter, acetylcholine. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.


    Lead Product(s): Glycopyrronium Bromide

    Therapeutic Area: Gastroenterology Brand Name: Glycopyrrolate-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 09, 2023

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    06

    Lupin Ltd

    India
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    Not Confirmed

    Lupin Ltd

    India
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    Not Confirmed
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    Lead Product(s) : Glycopyrronium Bromide

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Receives Approval From USFDA For Glycopyrrolate Injection USP

    Details : Glycopyrrolate is an anticholinergic agents, competitively inhibit binding of the neurotransmitter, acetylcholine. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions...

    Brand Name : Glycopyrrolate-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 09, 2023

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    Alembic Pharma Gets USFDA Nod For Generic Version Of Glycopyrrolate Injection

    Details:

    Glycopyrrolate injection is used as a pre-operative medication to inhibit salivary gland and respiratory secretions also as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.


    Lead Product(s): Glycopyrronium Bromide

    Therapeutic Area: Neurology Brand Name: Glycopyrrolate-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 01, 2022

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    07

    Alembic Pharmaceuticals Limited

    India
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    Not Confirmed

    Alembic Pharmaceuticals Limited

    India
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    Not Confirmed
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    Lead Product(s) : Glycopyrronium Bromide

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Pharma Gets USFDA Nod For Generic Version Of Glycopyrrolate Injection

    Details : Glycopyrrolate injection is used as a pre-operative medication to inhibit salivary gland and respiratory secretions also as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not t...

    Brand Name : Glycopyrrolate-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 01, 2022

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    Fresenius Kabi Expands Ready-to-Administer Portfolio with Glycopyrrolate Injection, USP Simplist® Prefilled Syringe

    Details:

    Glycopyrrolate Injection, USP 0.6 mg per 3 mL Simplist prefilled syringe may be administered prior to or concomitantly with Simplist Neostigmine Methylsulfate Injection, USP 3 mg per 3 mL prefilled syringe for reversal of neuromuscular blockade.


    Lead Product(s): Glycopyrronium Bromide

    Therapeutic Area: Neurology Brand Name: Glycopyrrolate-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 25, 2022

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    08

    Fresenius SE & Co. KGaA

    Germany
    arrow
    SupplySide West 2024
    Not Confirmed

    Fresenius SE & Co. KGaA

    Germany
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    Not Confirmed
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    Lead Product(s) : Glycopyrronium Bromide

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Fresenius Kabi Expands Ready-to-Administer Portfolio with Glycopyrrolate Injection, USP Simplist®...

    Details : Glycopyrrolate Injection, USP 0.6 mg per 3 mL Simplist prefilled syringe may be administered prior to or concomitantly with Simplist Neostigmine Methylsulfate Injection, USP 3 mg per 3 mL prefilled syringe for reversal of neuromuscular blockade.

    Brand Name : Glycopyrrolate-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 25, 2022

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    Honeywell Teams With AstraZeneca To Develop Next-Generation Respiratory Inhalers That Use Near-Zero Global Warming Potential Propellant

    Details:

    A recently completed Phase I clinical trial of the propellant HFO-1234ze in a pMDI containing budesonide, glycopyrronium, formoterol fumarate in healthy adults was positive, demonstrating similar safety and tolerability profile.


    Lead Product(s): Budesonide,Glycopyrronium Bromide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Breztri Aerosphere

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: AstraZeneca

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership February 22, 2022

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    09

    Honeywell

    U.S.A
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    Honeywell

    U.S.A
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    Lead Product(s) : Budesonide,Glycopyrronium Bromide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : AstraZeneca

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Honeywell Teams With AstraZeneca To Develop Next-Generation Respiratory Inhalers That Use Near-Zer...

    Details : A recently completed Phase I clinical trial of the propellant HFO-1234ze in a pMDI containing budesonide, glycopyrronium, formoterol fumarate in healthy adults was positive, demonstrating similar safety and tolerability profile.

    Brand Name : Breztri Aerosphere

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    February 22, 2022

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    Covis Enters Promotion and Distribution Agreement for Two Respiratory Medicines, Seebri® Breezhaler® and Ultibro® Breezhaler®, in Canada

    Details:

    Covis has entered into an Exclusive Promotion and Distribution Agreement with Novartis Pharmaceuticals Canada, whereby Covis has been appointed as Novartis’ exclusive partner to promote and distribute PrSeebri® Breezhaler® and PrUltibro® Breezhaler® in Canada.


    Lead Product(s): Glycopyrronium Bromide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Seebri Breezhaler

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Novartis Pharmaceuticals Corporation

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement January 05, 2022

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    10

    Covis Pharma

    Luxembourg
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    Not Confirmed

    Covis Pharma

    Luxembourg
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    Not Confirmed
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    Lead Product(s) : Glycopyrronium Bromide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Covis Enters Promotion and Distribution Agreement for Two Respiratory Medicines, Seebri® Breezhal...

    Details : Covis has entered into an Exclusive Promotion and Distribution Agreement with Novartis Pharmaceuticals Canada, whereby Covis has been appointed as Novartis’ exclusive partner to promote and distribute PrSeebri® Breezhaler® and PrUltibro® BreezhalerÂ...

    Brand Name : Seebri Breezhaler

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    January 05, 2022

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 1MG

    USFDA APPLICATION NUMBER - 12827

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    DOSAGE - TABLET;ORAL - 2MG

    USFDA APPLICATION NUMBER - 12827

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    DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML **Fe...DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17558

    read-more

    DOSAGE - POWDER;INHALATION - 15.6MCG/INH

    USFDA APPLICATION NUMBER - 207923

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    DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5...DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH

    USFDA APPLICATION NUMBER - 207930

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    DOSAGE - SOLUTION;INHALATION - 25MCG/ML

    USFDA APPLICATION NUMBER - 208437

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG

    USFDA APPLICATION NUMBER - 215019

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    Patents & EXCLUSIVITIES

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    US Patents

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    01

    ASTRAZENECA

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

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    Not Confirmed

    ASTRAZENECA

    United Kingdom
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    Not Confirmed

    Patent Expiration Date : 2030-05-28

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

    US Patent Number : 8324266

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 208294

    Patent Use Code : U-2889

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-05-28

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    02

    ASTRAZENECA

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

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    Not Confirmed

    ASTRAZENECA

    United Kingdom
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    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2030-05-28

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

    US Patent Number : 8703806

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 208294

    Patent Use Code : U-2889

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-05-28

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    03

    ASTRAZENECA AB

    BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

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    Not Confirmed

    ASTRAZENECA AB

    United Kingdom
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    Not Confirmed

    Patent Expiration Date : 2030-05-28

    BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

    US Patent Number : 9463161

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 212122

    Patent Use Code : U-2889

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-05-28

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    04

    ASTRAZENECA

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

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    Not Confirmed

    ASTRAZENECA

    United Kingdom
    arrow
    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2030-05-28

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

    US Patent Number : 9415009

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 208294

    Patent Use Code : U-2889

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-05-28

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    05

    ASTRAZENECA AB

    BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

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    Not Confirmed

    ASTRAZENECA AB

    United Kingdom
    arrow
    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2030-05-28

    BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

    US Patent Number : 10716753

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 212122

    Patent Use Code : U-2889

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-05-28

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    06

    ASTRAZENECA

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

    arrow
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    Not Confirmed

    ASTRAZENECA

    United Kingdom
    arrow
    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2030-05-28

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

    US Patent Number : 10716753

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 208294

    Patent Use Code : U-2889

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-05-28

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    07

    ASTRAZENECA AB

    BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

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    Not Confirmed

    ASTRAZENECA AB

    United Kingdom
    arrow
    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2030-05-28

    BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

    US Patent Number : 9415009

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 212122

    Patent Use Code : U-2889

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-05-28

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    08

    NOVARTIS

    GLYCOPYRROLATE

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    Not Confirmed

    NOVARTIS

    Switzerland
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    Not Confirmed

    Patent Expiration Date : 2028-10-11

    GLYCOPYRROLATE

    US Patent Number : 8479730

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 207923

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2028-10-11

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    09

    NOVARTIS

    GLYCOPYRROLATE; INDACATEROL MALEATE

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    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
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    Not Confirmed

    Patent Expiration Date : 2028-10-11

    GLYCOPYRROLATE; INDACATEROL MALEATE

    US Patent Number : 8479730

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 207930

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2028-10-11

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    10

    SUMITOMO PHARMA AM

    GLYCOPYRROLATE

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    Not Confirmed

    SUMITOMO PHARMA AM

    U.S.A
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    Not Confirmed

    Patent Expiration Date : 2024-11-18

    GLYCOPYRROLATE

    US Patent Number : 7458372

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 208437

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2024-11-18

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