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Insulin glargine recombinant - Generic Drug Details

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Insulin glargine recombinant is the generic ingredient in three branded drugs marketed by Sanofi Us Services and Sanofi Aventis Us, and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seventy-one patent family members in forty-one countries.

There are thirty-eight drug master file entries for insulin glargine recombinant. Six suppliers are listed for this compound.

Summary for Generic Name: insulin glargine recombinant

Tradenames:3
Patents:12
Applicants:2
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packaging: see list6
Drug Prices:see low prices

Pharmacology for Ingredient: insulin glargine recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYes8,512,297► subscribeY ► subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYes9,233,211► subscribeY ► subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYes8,992,486► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin glargine recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 20005,656,722*PED► subscribe
Sanofi Aventis Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 20006,100,376*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin glargine recombinant

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
9,028,454Drive mechanisms suitable for use in drug delivery devices► subscribe
8,888,750Pen-type injector► subscribe
8,070,727Drive 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 recombinant

Country Document Number Estimated Expiration
Portugal2266648► subscribe
Slovenia1601395► subscribe
Costa Rica20120578► 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 RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
226Luxembourg► subscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
00596Netherlands► subscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
C0035France► subscribePRODUCT NAME: INSULINE DEGLUTEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
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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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