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Last Updated: December 9, 2019

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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 patent protection?

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-two 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
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16

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 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   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 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 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 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
2107069 2013C/035 Belgium   Start Trial PRODUCT NAME: TRESIBA-INSULINE DEGLUDEC; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001 20130121
2498802 2017/022 Ireland   Start Trial PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0368187 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2498802 17C0004 France   Start Trial PRODUCT NAME: INSULINE GLARGINE ET LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
2209800 C02209800/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Express Scripts
Medtronic
Baxter
Colorcon

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