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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Citi
Express Scripts
McKinsey
Farmers Insurance
Teva
Medtronic
Fuji
Healthtrust
AstraZeneca

Generated: August 21, 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 freedom to operate?

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 list5,418
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
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-002Dec 20, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-002Dec 20, 2005RXYesYes► 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
9,604,009Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,905,867Pen-type injector► Subscribe
9,028,454Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,205,276Zinc-free and low-zinc insulin preparations having improved stability► Subscribe
8,021,345Pen-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 glulisine recombinant

Country Document Number Estimated Expiration
Austria497777► Subscribe
Germany602004028221► Subscribe
BrazilPI0408064► Subscribe
Turkey9801144► Subscribe
Spain2602814► 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
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Federal Trade Commission
Colorcon
Harvard Business School
Queensland Health
Teva
Argus Health
Johnson and Johnson
Novartis
Mallinckrodt

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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