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Insulin glargine recombinant - Generic Drug Details

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

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

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

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

Summary for Generic Name: insulin glargine recombinant

Tradenames:3
Patents:16
Applicants:2
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packagers: see list5
Clinical Trials: see list2,223
Drug Prices:see low prices
DailyMed Link:insulin glargine recombinant at DailyMed

Pharmacology for Ingredient: insulin glargine recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes9,408,979► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes9,011,391► Subscribe ► Subscribe
Sanofi Us Services
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes9,561,331► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 2000RXYesYes7,918,833*PED► SubscribeY► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes8,512,297► 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
7,905,867Pen-type injector► Subscribe
8,888,750Pen-type injector► Subscribe
8,070,727Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,021,345Pen-type injector► Subscribe
9,205,197Drug delivery device dose setting mechanism► 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
China103948913► Subscribe
Philippines12015501421► Subscribe
Japan2011241213► Subscribe
Japan5269945► Subscribe
Australia2010207716► 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
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
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
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
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
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