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Last Updated: January 20, 2020

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INSULIN GLARGINE RECOMBINANT - Generic Drug Details

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What are the generic drug sources for insulin glargine recombinant and what is the scope of freedom to operate?

Insulin glargine recombinant is the generic ingredient in four branded drugs marketed by Sanofi Aventis Us and Sanofi Us Services, and is included in two NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glargine recombinant has three hundred and sixty-six patent family members in fifty-two countries.

There are forty drug master file entries for insulin glargine recombinant. Three suppliers are listed for this compound.

Summary for INSULIN GLARGINE RECOMBINANT
Recent Clinical Trials for INSULIN GLARGINE RECOMBINANT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Hospital TuebingenPhase 4
The First Affiliated Hospital of Xiamen UniversityPhase 4
Sansum Diabetes Research InstitutePhase 4

See all INSULIN GLARGINE RECOMBINANT clinical trials

Recent Litigation for INSULIN GLARGINE RECOMBINANT

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MYLAN N v.2017-10-24
SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP.2017-08-08
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30

See all INSULIN GLARGINE RECOMBINANT litigation

PTAB Litigation
PetitionerDate
Pfizer Inc.2019-05-02
Mylan Pharmaceuticals Inc.2018-10-29
Mylan Pharmaceuticals Inc2018-09-10

See all INSULIN GLARGINE RECOMBINANT litigation

Pharmacology for INSULIN GLARGINE RECOMBINANT
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for INSULIN GLARGINE RECOMBINANT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Us Services TOUJEO MAX SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-002 Mar 26, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Us Services TOUJEO MAX SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-002 Mar 26, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for INSULIN GLARGINE RECOMBINANT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000   Start Trial   Start Trial
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for INSULIN GLARGINE RECOMBINANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2340033 300880 Netherlands   Start Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2498802 PA2017020 Lithuania   Start Trial PRODUCT NAME: INSULINAS GLARGINAS + LIKSIZENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0792290 PA2004005 Lithuania   Start Trial PRODUCT NAME: INSULIN DETEMIR
2107069 1390036-0 Sweden   Start Trial PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Baxter
Merck
Harvard Business School
McKesson

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