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Last Updated: February 19, 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 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 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

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

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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
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16

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

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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
Sanofi-aventis Us SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial   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
1196444 29/2013 Austria   Start Trial PRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
2107069 C 2013 019 Romania   Start Trial PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA: 20130121
2107069 1390036-0 Sweden   Start Trial PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
0885961 C00885961/01 Switzerland   Start Trial PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.