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Last Updated: March 30, 2020

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SOLIQUA 100/33 Drug Profile


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Which patents cover Soliqua 100/33, 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. 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
2019-05-02
Pfizer Inc.2019-05-02
Mylan Pharmaceuticals Inc.2018-10-29

See all SOLIQUA 100/33 litigation

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
>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 92213 Luxembourg   Start Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001-4-5-7-8-9-12-13-15 TRESIBA 20130123
0705275 C300021 Netherlands   Start Trial PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
0792290 PA2004005 Lithuania   Start Trial PRODUCT NAME: INSULIN DETEMIR
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Mallinckrodt
Merck
Express Scripts
Dow

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 verification 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.