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INSULIN GLARGINE; LIXISENATIDE - Generic Drug Details

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

This ingredient has one hundred and fifty-six patent family members in twenty-seven 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:12
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packagers: see list1
Clinical Trials: see list1,666
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: INSULIN GLARGINE; LIXISENATIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYes8,679,069► subscribeY ► subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYes8,512,297► subscribeY ► subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYes9,233,211► 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
8,070,727Drive mechanisms suitable for use in drug delivery devices► subscribe
9,028,454Drive mechanisms suitable for use in drug delivery devices► subscribe
8,888,750Pen-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
European Patent Office1974761► subscribe
Hong Kong1094544► subscribe
Japan2006519074► 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
/2000Austria► subscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2004005,C0792290Lithuania► subscribePRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
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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.

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