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Generated: July 28, 2017

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INSULIN GLULISINE RECOMBINANT - Generic Drug Details

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

Insulin glulisine recombinant
is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us and is included in one NDA. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glulisine recombinant has two hundred and twenty-one patent family members in forty-two countries.

There are thirty-eight drug master file entries for insulin glulisine recombinant. One supplier is listed for this compound.

Summary for Generic Name: INSULIN GLULISINE RECOMBINANT

Tradenames:2
Patents:19
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packagers: see list1
Clinical Trials: see list5,397
Drug Prices:see low prices
DailyMed Link:INSULIN GLULISINE RECOMBINANT at DailyMed

Pharmacology for Ingredient: INSULIN GLULISINE 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
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin glulisine 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
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,876,782Drive 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
9,028,454Drive 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 glulisine recombinant

Country Document Number Estimated Expiration
Canada2518015► Subscribe
Denmark1944050► Subscribe
Cyprus1108189► Subscribe
Israel214157► Subscribe
TaiwanI323180► 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 GLULISINE RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/036United Kingdom► SubscribePRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
00160Netherlands► SubscribePRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
US Army
Cantor Fitzgerald
AstraZeneca
Medtronic
Harvard Business School
Novartis
Moodys
Farmers Insurance

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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