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Last Updated: January 23, 2020

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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 seventy-one 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.

US ANDA Litigation and Generic Entry Outlook for Soliqua 100/33

Soliqua 100/33 will be eligible for patent challenges on July 27, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 9, 2029. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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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
SanofiPhase 4
LMC Diabetes & Endocrinology Ltd.Phase 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
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 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
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
1196444 456 Finland   Start Trial
2498802 285 12-2017 Slovakia   Start Trial PRODUCT NAME: INZULIN GLARGIN/LIXISENATID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1157 20170113
2107069 2013C/038 Belgium   Start Trial PRODUCT NAME: RYZODEG-INSULINE DEGLUDEC/INSULINE ASPARTE; AUTHORISATION NUMBER AND DATE: EU/1/12/806/001 20130121
2597103 CR 2017 00013 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
2340033 2017C/024 Belgium   Start Trial PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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