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    Chemistry

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    Also known as: 140462-76-6, Olopatadine hcl, Allelock, Pataday, Patanase, Alo4943a
    Molecular Formula
    C21H24ClNO3
    Molecular Weight
    373.9  g/mol
    InChI Key
    HVRLZEKDTUEKQH-NOILCQHBSA-N
    FDA UNII
    2XG66W44KF
    Olopatadine Hydrochloride
    An antihistamine with mast-cell stabilizing properties used as eye drops in the treatment of ALLERGIC CONJUNCTIVITIS.
    1 2D Structure

    Olopatadine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid;hydrochloride
    2.1.2 InChI
    InChI=1S/C21H23NO3.ClH/c1-22(2)11-5-8-18-17-7-4-3-6-16(17)14-25-20-10-9-15(12-19(18)20)13-21(23)24;/h3-4,6-10,12H,5,11,13-14H2,1-2H3,(H,23,24);1H/b18-8-;
    2.1.3 InChI Key
    HVRLZEKDTUEKQH-NOILCQHBSA-N
    2.1.4 Canonical SMILES
    CN(C)CCC=C1C2=CC=CC=C2COC3=C1C=C(C=C3)CC(=O)O.Cl
    2.1.5 Isomeric SMILES
    CN(C)CC/C=C\1/C2=CC=CC=C2COC3=C1C=C(C=C3)CC(=O)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    2XG66W44KF
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid

    2. 4679, Kw

    3. Hydrochloride, Olopatadine

    4. Kw 4679

    5. Kw 4943a

    6. Kw-4679

    7. Kw-4943a

    8. Kw4943a

    9. Olopatadine

    10. Patanol

    2.3.2 Depositor-Supplied Synonyms

    1. 140462-76-6

    2. Olopatadine Hcl

    3. Allelock

    4. Pataday

    5. Patanase

    6. Alo4943a

    7. Pazeo

    8. Kw4679

    9. Kw-4679

    10. Olopatadine (hydrochloride)

    11. Alo-4943a

    12. (z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetic Acid Hydrochloride

    13. Olopatadine (as Hydrochloride)

    14. 2xg66w44kf

    15. Dsstox_cid_26486

    16. Dsstox_rid_81657

    17. Dsstox_gsid_46486

    18. Dibenz(b,e)oxepin-2-acetic Acid, 11-(3-(dimethylamino)propylidene)-6,11-dihydro-, Hydrochloride, (z)-

    19. Olopine

    20. Patadine

    21. Olopax

    22. Chembl1719

    23. Kw 4679

    24. Cas-140462-76-6

    25. Opatanol (tn)

    26. Unii-2xg66w44kf

    27. Sr-01000763388

    28. Alo 4943a

    29. Olopatadine Hydrochloride [usan]

    30. Allelock (tn)

    31. Patanol (tn)

    32. De 114

    33. Mfcd00875716

    34. Olopatadine Hydrochloride [usan:usp]

    35. Olopatadine Hydrochlorde

    36. O-ppds

    37. Ncgc00164623-01

    38. Schembl23213

    39. Mls001401465

    40. Dtxsid0046486

    41. Chebi:31933

    42. Hy-b0426a

    43. Olopatadine Hydrochloride- Bio-x

    44. Al4943a

    45. Alo4943a;kw4679

    46. 2-[(11z)-11-[3-(dimethylamino)propylidene]-6h-benzo[c][1]benzoxepin-2-yl]acetic Acid;hydrochloride

    47. Dibenz[b,e]oxepin-2-acetic Acid, 11-[3-(dimethylamino)propylidene]-6,11-dihydro-, Hydrochloride (1:1), (11z)-

    48. Ex-a1347

    49. Olopatadine Hydrochloride (opatanol)

    50. Tox21_112242

    51. S2494

    52. Olopatadine Hydrochloride [mi]

    53. Akos015895232

    54. Akos025149118

    55. Olopatadine Hydrochloride (jp17/usp)

    56. Tox21_112242_1

    57. Bcp9001022

    58. Ccg-101141

    59. H06o056

    60. Ks-1228

    61. Nc00391

    62. Olopatadine Hydrochloride [jan]

    63. Ncgc00263532-01

    64. Olopatadine Hydrochloride [mart.]

    65. Olopatadine Hydrochloride [vandf]

    66. 11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid Hydrochloride

    67. 11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid, Hydrochloride

    68. Bo164171

    69. Dibenz(b,e)oxepin-2-acetic Acid, 11-(3-dimethylamino)propylidene)-6,11-dihydro-, Hydrochloride, (z)-

    70. Olopatadine Hydrochloride [usp-rs]

    71. Olopatadine Hydrochloride [who-dd]

    72. Smr000469220

    73. Olopatadine Hydrochloride, >=98% (hplc)

    74. Olopatadine Hydrochloride [ema Epar]

    75. O0361

    76. C72607

    77. D01192

    78. Olopatadine Hydrochloride [orange Book]

    79. Olopatadine Hydrochloride [usp Monograph]

    80. A807652

    81. Ryaltris Component Olopatadine Hydrochloride

    82. Q-201511

    83. Sr-01000763388-4

    84. Olopatadine Hydrochloride Component Of Ryaltris

    85. Q27255766

    86. Olopatadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    87. (z)-11-[3-(dimethylamino)propylidene]-6,11-dihydro-dibenz[b,e]oxepin-2-acetic Acid Hydrochloride

    88. (z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)aceticacidhydrochloride

    2.4 Create Date
    2005-10-11
    3 Chemical and Physical Properties
    Molecular Weight 373.9 g/mol
    Molecular Formula C21H24ClNO3
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count5
    Exact Mass373.1444713 g/mol
    Monoisotopic Mass373.1444713 g/mol
    Topological Polar Surface Area49.8 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity488
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameOlopatadine hydrochloride
    Drug LabelOlopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Solution (Nasal Spray), is a wh...
    Active IngredientOlopatadine hydrochloride
    Dosage FormSolution/drops; Spray, metered; Solution
    RouteOphthalmic; Nasal; ophthalmic
    Strength0.665mg/spray; 0.2% base; 0.1%; eq 0.1% base; 0.2%
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; Apotex; Sandoz; Watson Labs; Barr

    2 of 8  
    Drug NamePataday
    Drug LabelPATADAY (olopatadine hydrochloride ophthalmic solution) 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes.Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular we...
    Active IngredientOlopatadine hydrochloride
    Dosage FormSolution/drops
    RouteOphthalmic
    Strengtheq 0.2% base
    Market StatusPrescription
    CompanyAlcon Pharms

    3 of 8  
    Drug NamePatanase
    PubMed HealthOlopatadine (Into the nose)
    Drug ClassesNasal Agent
    Drug LabelPATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. T...
    Active IngredientOlopatadine hydrochloride
    Dosage FormSpray, metered
    RouteNasal
    Strength0.665mg/spray
    Market StatusPrescription
    CompanyAlcon Pharms

    4 of 8  
    Drug NamePatanol
    PubMed HealthOlopatadine
    Drug ClassesNasal Agent, Ophthalmologic Agent
    Drug LabelPATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to...
    Active IngredientOlopatadine hydrochloride
    Dosage FormSolution/drops
    RouteOphthalmic
    Strengtheq 0.1% base
    Market StatusPrescription
    CompanyAlcon

    5 of 8  
    Drug NameOlopatadine hydrochloride
    Drug LabelOlopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Solution (Nasal Spray), is a wh...
    Active IngredientOlopatadine hydrochloride
    Dosage FormSolution/drops; Spray, metered; Solution
    RouteOphthalmic; Nasal; ophthalmic
    Strength0.665mg/spray; 0.2% base; 0.1%; eq 0.1% base; 0.2%
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; Apotex; Sandoz; Watson Labs; Barr

    6 of 8  
    Drug NamePataday
    Drug LabelPATADAY (olopatadine hydrochloride ophthalmic solution) 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes.Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular we...
    Active IngredientOlopatadine hydrochloride
    Dosage FormSolution/drops
    RouteOphthalmic
    Strengtheq 0.2% base
    Market StatusPrescription
    CompanyAlcon Pharms

    7 of 8  
    Drug NamePatanase
    PubMed HealthOlopatadine (Into the nose)
    Drug ClassesNasal Agent
    Drug LabelPATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. T...
    Active IngredientOlopatadine hydrochloride
    Dosage FormSpray, metered
    RouteNasal
    Strength0.665mg/spray
    Market StatusPrescription
    CompanyAlcon Pharms

    8 of 8  
    Drug NamePatanol
    PubMed HealthOlopatadine
    Drug ClassesNasal Agent, Ophthalmologic Agent
    Drug LabelPATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to...
    Active IngredientOlopatadine hydrochloride
    Dosage FormSolution/drops
    RouteOphthalmic
    Strengtheq 0.1% base
    Market StatusPrescription
    CompanyAlcon

    4.2 Drug Indication

    Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Inflammatory Agents, Non-Steroidal

    Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

    Histamine H1 Antagonists, Non-Sedating

    A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)

    Anti-Allergic Agents

    Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]; Histamine-1 Receptor Inhibitor [EPC]; Mast Cell Stabilizer [EPC]; Decreased Histamine Release [PE]
    5.3 ATC Code

    S01GX09

    API Reference Price

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    05-Jan-2021
    27-Dec-2024
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE

    USFDA APPLICATION NUMBER - 206276

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    DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE

    USFDA APPLICATION NUMBER - 20688

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    DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE

    USFDA APPLICATION NUMBER - 21545

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    DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY

    USFDA APPLICATION NUMBER - 21861

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    ABOUT THIS PAGE

    Olopatadine Hydrochloride Manufacturers

    A Olopatadine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olopatadine Hydrochloride, including repackagers and relabelers. The FDA regulates Olopatadine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olopatadine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Olopatadine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Olopatadine Hydrochloride Suppliers

    A Olopatadine Hydrochloride supplier is an individual or a company that provides Olopatadine Hydrochloride active pharmaceutical ingredient (API) or Olopatadine Hydrochloride finished formulations upon request. The Olopatadine Hydrochloride suppliers may include Olopatadine Hydrochloride API manufacturers, exporters, distributors and traders.

    click here to find a list of Olopatadine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Olopatadine Hydrochloride USDMF

    A Olopatadine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Olopatadine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Olopatadine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Olopatadine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Olopatadine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Olopatadine Hydrochloride USDMF includes data on Olopatadine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olopatadine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Olopatadine Hydrochloride suppliers with USDMF on PharmaCompass.

    Olopatadine Hydrochloride JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Olopatadine Hydrochloride Drug Master File in Japan (Olopatadine Hydrochloride JDMF) empowers Olopatadine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Olopatadine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Olopatadine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Olopatadine Hydrochloride suppliers with JDMF on PharmaCompass.

    Olopatadine Hydrochloride KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Olopatadine Hydrochloride Drug Master File in Korea (Olopatadine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Olopatadine Hydrochloride. The MFDS reviews the Olopatadine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Olopatadine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Olopatadine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Olopatadine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Olopatadine Hydrochloride suppliers with KDMF on PharmaCompass.

    Olopatadine Hydrochloride WC

    A Olopatadine Hydrochloride written confirmation (Olopatadine Hydrochloride WC) is an official document issued by a regulatory agency to a Olopatadine Hydrochloride manufacturer, verifying that the manufacturing facility of a Olopatadine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Olopatadine Hydrochloride APIs or Olopatadine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Olopatadine Hydrochloride WC (written confirmation) as part of the regulatory process.

    click here to find a list of Olopatadine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

    Olopatadine Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Olopatadine Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Olopatadine Hydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Olopatadine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Olopatadine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Olopatadine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Olopatadine Hydrochloride suppliers with NDC on PharmaCompass.

    Olopatadine Hydrochloride GMP

    Olopatadine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Olopatadine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Olopatadine Hydrochloride GMP manufacturer or Olopatadine Hydrochloride GMP API supplier for your needs.

    Olopatadine Hydrochloride CoA

    A Olopatadine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Olopatadine Hydrochloride's compliance with Olopatadine Hydrochloride specifications and serves as a tool for batch-level quality control.

    Olopatadine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Olopatadine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Olopatadine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Olopatadine Hydrochloride EP), Olopatadine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olopatadine Hydrochloride USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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