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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
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Generated: June 28, 2017

DrugPatentWatch Database Preview

Insulin glargine recombinant - Generic Drug Details

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What are the generic drug sources for insulin glargine recombinant and what is the scope of insulin glargine recombinant patent protection?

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

Insulin glargine recombinant has one hundred and ninety-five patent family members in forty-two countries.

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

Summary for Generic Name: insulin glargine recombinant

Tradenames:3
Patents:20
Applicants:2
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packagers: see list4
Clinical Trials: see list5,367
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 TE 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, 2007RXYesYes9,604,009► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes9,561,331► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYesYes9,623,189► SubscribeY ► Subscribe
Sanofi Aventis Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 2000RXYesYes7,476,652*PED► SubscribeY► Subscribe
Sanofi Us Services
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS206538-001Feb 25, 2015RXYesYes9,610,409► 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
7,935,088Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,028,454Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,070,727Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,905,867Pen-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 recombinant

Country Document Number Estimated Expiration
China100443128► Subscribe
Hong Kong1202428► Subscribe
Cyprus1108581► Subscribe
European Patent Office2210634► Subscribe
Denmark2263724► 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
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/004 20130123
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Julphar
Farmers Insurance
Federal Trade Commission
Argus Health
Deloitte
Teva
Medtronic
McKinsey
Colorcon

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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