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INSULIN GLARGINE; LIXISENATIDE - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for insulin glargine; lixisenatide?

Insulin glargine; lixisenatide is the generic ingredient in one branded drug marketed by Sanofi-aventis Us and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and ninety-eight patent family members in thirty-nine countries.

There are thirty-eight drug master file entries for insulin glargine; lixisenatide. One supplier is listed for this compound.

Summary for Generic Name: INSULIN GLARGINE; LIXISENATIDE

Tradenames:1
Patents:15
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packagers: see list1
Clinical Trials: see list1,666
Drug Prices:see low prices
DailyMed Link:INSULIN GLARGINE; LIXISENATIDE at DailyMed

Pharmacology for Ingredient: INSULIN GLARGINE; LIXISENATIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYesRE45313► SubscribeYY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes8,603,044► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes9,233,211► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes9,533,105► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin glargine; lixisenatide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,205,197Drug delivery device dose setting mechanism► Subscribe
8,888,750Pen-type injector► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
6,528,486 Peptide agonists of GLP-1 activity► Subscribe
8,021,345Pen-type injector► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: insulin glargine; lixisenatide

Country Document Number Estimated Expiration
Japan4939211► Subscribe
Japan2006519078► Subscribe
Portugal1601397► Subscribe
European Patent Office1196444► Subscribe
Denmark1974761► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: INSULIN GLARGINE; LIXISENATIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009France► SubscribePRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
175Luxembourg► SubscribePRODUCT NAME: LIXISENATIDE
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
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