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Last Updated: October 21, 2019

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SOLIQUA 100/33 Drug Profile

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When do Soliqua 100/33 patents expire, and when can generic versions of Soliqua 100/33 launch?

Soliqua 100/33 is a drug marketed by Sanofi-aventis Us and is included in one NDA. There are twenty-six patents protecting this drug.

This drug has four hundred and fifty-six patent family members in fifty countries.

The generic ingredient in SOLIQUA 100/33 is insulin glargine; lixisenatide. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glargine; lixisenatide profile page.

Drug patent expirations by year for SOLIQUA 100/33
Generic Entry Opportunity Date for SOLIQUA 100/33
Generic Entry Date for SOLIQUA 100/33*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SOLIQUA 100/33

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

SponsorPhase
LMC Diabetes & Endocrinology Ltd.Phase 4
SanofiPhase 4
SanofiPhase 3

See all SOLIQUA 100/33 clinical trials

Recent Litigation for SOLIQUA 100/33

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

See all SOLIQUA 100/33 litigation

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

See all SOLIQUA 100/33 litigation

Pharmacology for SOLIQUA 100/33

US Patents and Regulatory Information for SOLIQUA 100/33

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   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
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 SOLIQUA 100/33

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 C 2013 022 Romania   Start Trial PRODUCT NAME: COMBINATIE DE INSULINA DEGLUDEC SI INSULINA ASPART IN TOATEFORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001,EU/1/12/806/004,EU/1/12/806/005,EU/1/12/806/007,00; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, 00; DATE OF FIRST AUTHORISATION IN EEA: 20130121
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
0214826 99C0044 Belgium   Start Trial PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
1196444 456 Finland   Start Trial
1196444 2013C/033 Belgium   Start Trial PRODUCT NAME: LYXUMIA-LIXISENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/12/811/001 20130205
0383472 C960026 Netherlands   Start Trial PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
2107069 35/2013 Austria   Start Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC AND INSULIN ASPART UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, EU/1/12/806/008 (MITTEILUNG) 20180123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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