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1. 901, Hoe
2. A21 Gly B31 Arg B32 Arg Insulin
3. A21-gly-b31-arg-b32-arg-insulin
4. Basaglar
5. Glargine
6. Glargine, Insulin
7. Glargine-aglr, Insulin
8. Hoe 901
9. Hoe-901
10. Hoe901
11. Insulin Glargine
12. Insulin Glargine-aglr
13. Insulin Glargine-yfgn
14. Insulin, Gly(a21)-arg(b31,b32)
15. Insulin, Glycyl(a21)-arginyl(b31,b32)
16. Lantus
17. Lantus Solostar
18. Rezvoglar
19. Semglee
20. Solostar, Lantus
1. Gtpl7572
2. Hoe901
3. Hoe-901
Molecular Weight | 6063 g/mol |
---|---|
Molecular Formula | C267H404N72O78S6 |
XLogP3 | -14.1 |
Hydrogen Bond Donor Count | 85 |
Hydrogen Bond Acceptor Count | 92 |
Rotatable Bond Count | 191 |
Exact Mass | 6060.8251182 g/mol |
Monoisotopic Mass | 6058.8184085 g/mol |
Topological Polar Surface Area | 2590 Ų |
Heavy Atom Count | 423 |
Formal Charge | 0 |
Complexity | 15300 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 53 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Lantus |
PubMed Health | Insulin Glargine |
Drug Classes | Antidiabetic, Insulin, Long Acting |
Drug Label | LANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenter... |
Active Ingredient | Insulin glargine recombinant |
Dosage Form | Injectable |
Route | Injection |
Strength | 100 units/ml |
Market Status | Prescription |
Company | Sanofi Aventis Us |
2 of 2 | |
---|---|
Drug Name | Lantus |
PubMed Health | Insulin Glargine |
Drug Classes | Antidiabetic, Insulin, Long Acting |
Drug Label | LANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenter... |
Active Ingredient | Insulin glargine recombinant |
Dosage Form | Injectable |
Route | Injection |
Strength | 100 units/ml |
Market Status | Prescription |
Company | Sanofi Aventis Us |
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27093
Submission : 2013-05-24
Status : Active
Type : II
Registration Number : 226MF10213
Registrant's Address : Biocon House, Ground Floor, Tower-3, Semicon Park, Electronic City, Phase-II, Hosur Road, Bengaluru-560100
Initial Date of Registration : 2014-11-17
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36695
Submission : 2022-02-16
Status : Active
Type : II
Date of Issue : 2017-11-07
Valid Till : 2020-11-07
Written Confirmation Number : WC-0414
Address of the Firm :
About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...
About the Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom synthesis and manufact...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Brand Name: Soliqua
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2023
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sanofi Launches New Long-Acting Insulin Drug in India
Details : Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.
Brand Name : Soliqua
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 27, 2023
Details:
Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Brand Name: Soliqua
Study Phase: UndisclosedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2021
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
New Soliqua® Data Shows Improved Blood Sugar Control Without Weight Gain Versus Premixed Insulin
Details : Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.
Brand Name : Soliqua
Molecule Type : Peptide
Upfront Cash : Not Applicable
June 28, 2021
Details:
Civica plans to produce three insulin biosimilars – glargine, lispro and aspart – each of which will be available both in vials and prefilled pens, and to ensure redundancy of supply, Ypsomed will provide injector dosing pens from their manufacturing facilities.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Peptide
Sponsor: Civica Rx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 31, 2023
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Civica Rx
Deal Size : Undisclosed
Deal Type : Partnership
Civica Welcomes Ypsomed as Injection Pen Partner for Its Affordable Insulin Initiative
Details : Civica plans to produce three insulin biosimilars – glargine, lispro and aspart – each of which will be available both in vials and prefilled pens, and to ensure redundancy of supply, Ypsomed will provide injector dosing pens from their manufacturing...
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Undisclosed
January 31, 2023
Details:
Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer reported sales are less.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Glaricon
Study Phase: ApprovedProduct Type: Peptide
Sponsor: HEC Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : HEC Group
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer re...
Brand Name : Glaricon
Molecule Type : Peptide
Upfront Cash : Not Applicable
August 31, 2022
Details:
The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: HEC-Glargine
Study Phase: Phase IProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lannett Initiates Pivotal Clinical Trial for Biosimilar Insulin Glargine
Details : The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.
Brand Name : HEC-Glargine
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 29, 2022
Details:
Civica will produce three insulins – glargine, lispro and aspart (biologics corresponding to, and interchangeable with, Lantus, Humalog and Novolog respectively) – each of which will be available both in vials and prefilled pens.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Insulin Glargine-Generic
Study Phase: PreclinicalProduct Type: Peptide
Sponsor: GeneSys Biologics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing March 03, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : GeneSys Biologics
Deal Size : Undisclosed
Deal Type : Financing
Civica Takes First Foray Into Biosimilars With GeneSys Insulins Partnership
Details : Civica will produce three insulins – glargine, lispro and aspart (biologics corresponding to, and interchangeable with, Lantus, Humalog and Novolog respectively) – each of which will be available both in vials and prefilled pens.
Brand Name : Insulin Glargine-Generic
Molecule Type : Peptide
Upfront Cash : Undisclosed
March 03, 2022
Details:
The acquisition of biosimilars assets of Viatris significantly strengthens BBL’s position in providing affordable access to patients through its portfolio in diabetes, oncology, immunology and other non-communicable diseases including Semglee (Insulin Glargine-yfgn).
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Semglee
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Biocon
Deal Size: $3,335.0 million Upfront Cash: $2,335.0 million
Deal Type: Acquisition February 28, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Biocon
Deal Size : $3,335.0 million
Deal Type : Acquisition
Biocon Biologics to Acquire Viatris’ Biosimilars Assets for up to USD 3.335 billion in Stock and...
Details : The acquisition of biosimilars assets of Viatris significantly strengthens BBL’s position in providing affordable access to patients through its portfolio in diabetes, oncology, immunology and other non-communicable diseases including Semglee (Insulin ...
Brand Name : Semglee
Molecule Type : Peptide
Upfront Cash : $2,335.0 million
February 28, 2022
Details:
The Semglee® (insulin glargine injection), is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefilled pens.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Semglee
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Biocon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Biocon
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The Semglee® (insulin glargine injection), is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefille...
Brand Name : Semglee
Molecule Type : Peptide
Upfront Cash : Not Applicable
January 18, 2022
Details:
Decisions reaffirm Viatris' ability to provide patient access to interchangeable for the reference brand, Lantus®, allowing for substitution at the pharmacy counter. Semglee® is indicated to help control high blood sugar with type 1 diabetes and type 2 diabetes.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Semglee
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2021
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Viatris Wins Court Decisions on Sanofi Appeals of Lantus® Patent Invalidations
Details : Decisions reaffirm Viatris' ability to provide patient access to interchangeable for the reference brand, Lantus®, allowing for substitution at the pharmacy counter. Semglee® is indicated to help control high blood sugar with type 1 diabetes and type 2...
Brand Name : Semglee
Molecule Type : Peptide
Upfront Cash : Not Applicable
December 29, 2021
Details:
Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorisation for select speciality products including Glaricon and be responsible to register, importing, and promoting them in Saudi Arabia and other Middle East countries.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Glaricon
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Biocon
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 07, 2021
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Biocon
Deal Size : Undisclosed
Deal Type : Agreement
Details : Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorisation for select speciality products including Glaricon and be responsible to register, importing, and promoting them in Saudi Arabia and other Middle East countries...
Brand Name : Glaricon
Molecule Type : Peptide
Upfront Cash : Undisclosed
December 07, 2021
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Lantus (ClikSTAR others. Pens)
Dosage Form : SOLUTION FOR INJECTION IN CARTRIDGE
Dosage Strength : 100 UNITS / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Lantus (OptiClik)
Dosage Form : SOLUTION FOR INJECTION IN CARTRIDGE
Dosage Strength : 100 UNITS / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Toujeo
Dosage Form : SOLUTION FOR INJECTION IN PRE-FILLED
Dosage Strength : 100 UNITS / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Toujeo
Dosage Form : SOLUTION FOR INJECTION IN PRE-FILLED
Dosage Strength : 300 UNITS / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Lantus
Dosage Form : Insulin Glargine 1.000Iu 10Ml 1 Units Parenteral Use
Dosage Strength : 1 vial SC 1,000 IU 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Lantus
Dosage Form : Insulin Glargine 100Iu/Ml 3Ml 5 Units Parenteral Use
Dosage Strength : 5 cartridges SC 100 IU/ml 3 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Lantus
Dosage Form : Injection fluid, resolution in the finished filled pen
Dosage Strength : 100 E/ml
Packaging : Finish filled pen, solo star
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Toujeo
Dosage Form : Injection fluid, resolution
Dosage Strength : 300 E/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Toujeo
Dosage Form : Injection fluid, resolution
Dosage Strength : 300 E/ml
Packaging : Finish filled pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Insulinum glarginum; Lixisenatidum
Brand Name : Suliqua 100/33
Dosage Form : Inj Loose Solostar
Dosage Strength : 100/33
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 300IU/3ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 300IU/3ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Related Excipient Companies
Dosage Form : Softgel Capsule
Grade : Not Available
Application : Solubilizers
Excipient Details : Nonionic solubilizer, emulsifier and co-emulsifier
Excipients by Applications
Global Sales Information
Main Therapeutic Indication : Diabetes
Currency : USD
2014 Revenue in Millions : 11.00%
2013 Revenue in Millions :
Growth (%) :
Main Therapeutic Indication : Diabetes
Currency : USD
2019 Revenue in Millions : 3,283
2018 Revenue in Millions : 3,886
Growth (%) : -16
Main Therapeutic Indication : Diabetes
Currency : USD
2019 Revenue in Millions : 962
2018 Revenue in Millions : 916
Growth (%) : 5
Main Therapeutic Indication : Diabetes
Currency : USD
2020 Revenue in Millions : 1,129
2019 Revenue in Millions : 1,068
Growth (%) : 6
Main Therapeutic Indication : Diabetes
Currency : USD
2020 Revenue in Millions : 195
2019 Revenue in Millions : 148
Growth (%) : 32
Main Therapeutic Indication : Diabetes
Currency : USD
2020 Revenue in Millions : 3,219
2019 Revenue in Millions : 3,643
Growth (%) : -12
Main Therapeutic Indication : Diabetes
Currency : USD
2021 Revenue in Millions : 2,746
2020 Revenue in Millions : 2,900
Growth (%) : -6
Main Therapeutic Indication : Diabetes
Currency : USD
2021 Revenue in Millions : 1,067
2020 Revenue in Millions : 1,017
Growth (%) : 4
Main Therapeutic Indication : Diabetes
Currency : USD
2021 Revenue in Millions : 215
2020 Revenue in Millions : 175
Growth (%) : 21
Main Therapeutic Indication : Diabetes
Currency : USD
2022 Revenue in Millions : 1,225
2021 Revenue in Millions : 1,067
Growth (%) : 15
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