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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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and sixty 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:13
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
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, 2016RXYesYes9,408,979► subscribeY ► subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes9,561,331► subscribeY ► subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes8,679,069► 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
9,526,843Drive mechanisms suitable for use in drug delivery devices► subscribe
8,888,750Pen-type injector► subscribe
8,574,198Drive mechanisms suitable for use in drug delivery devices► 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
Canada2518015► subscribe
Portugal1920794► subscribe
Denmark1603610► 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
2013 00018Denmark► subscribe
C/GB05/024United Kingdom► subscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
/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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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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