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Last Updated: November 13, 2019

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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 patent protection?

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 fifty-six 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

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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

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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.2016-09-16
Sanofi-Aventis U.S. LLC v. Eli Lilly and Company2014-01-30

See all INSULIN GLARGINE; LIXISENATIDE litigation

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

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
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
1196444 C01196444/01 Switzerland   Start Trial PRODUCT NAME: LIXISENATIDUM; REGISTRATION NO/DATE: SWISSMEDIC 65958 28.03.2017
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2107069 2013C/035 Belgium   Start Trial PRODUCT NAME: TRESIBA-INSULINE DEGLUDEC; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001 20130121
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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