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Last Updated: February 27, 2020

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Insulin glargine; lixisenatide - Generic Drug Details

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

Insulin glargine; lixisenatide is the generic ingredient in one branded drug marketed by Sanofi-aventis Us and is included in one NDA. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glargine; lixisenatide has four hundred and seventy-one patent family members in fifty countries.

There are forty drug master file entries for insulin glargine; lixisenatide. One supplier is listed for this compound.

Summary for insulin glargine; lixisenatide
Recent Clinical Trials for insulin glargine; lixisenatide

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

SponsorPhase
University Hospital TuebingenPhase 4
Medical University of ViennaPhase 3
VU University Medical CenterPhase 4

See all insulin glargine; lixisenatide clinical trials

Recent Litigation for insulin glargine; lixisenatide

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MYLAN N v.2017-10-24
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16

See all insulin glargine; lixisenatide litigation

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

See all insulin glargine; lixisenatide litigation

Pharmacology for insulin glargine; lixisenatide

US Patents and Regulatory Information for insulin glargine; lixisenatide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi-aventis Us SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673-001 Nov 21, 2016 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

Supplementary Protection Certificates for insulin glargine; lixisenatide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 SPC/GB13/037 United Kingdom   Start Trial PRODUCT NAME: INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, COMPLEXES, OR SALTS THEREOF; REGISTERED: UK EU/1/12/807/001 20130123; UK EU/1/12/807/004 20130123; UK EU/1/12/807/005 20130123; UK EU/1/12/807/007 20130123; UK EU/1/12/807/008 20130123; UK EU/1/12/807/009 20130123; UK EU/1/12/807/012 20130123; UK EU/1/12/807/013 20130123; UK EU/1/12/807/015 20130123
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
1196444 122013000036 Germany   Start Trial PRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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