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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Teva
Harvard Business School
Julphar
Farmers Insurance
Dow
Cerilliant
Johnson and Johnson
Colorcon

Generated: October 24, 2017

DrugPatentWatch Database Preview

APIDRA Drug Profile

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What is the patent landscape for Apidra, and what generic Apidra alternatives are available?

Apidra is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are twenty patents protecting this drug.

This drug has eighty-eight patent family members in thirty-nine countries and forty-four supplementary protection certificates in twelve countries.

The generic ingredient in APIDRA is insulin glulisine recombinant. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.

Summary for Tradename: APIDRA

US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list50
Drug Prices:see details
DailyMed Link:APIDRA at DailyMed

Pharmacology for Tradename: APIDRA

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
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
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
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe ► 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
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Non-Orange Book Patents for Tradename: APIDRA

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
7,205,276Zinc-free and low-zinc insulin preparations having improved stability► Subscribe
7,205,277Zinc-free and low-zinc insulin preparations having improved stability► 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 Tradename: APIDRA

Country Document Number Estimated Expiration
Poland362800► Subscribe
Canada2441260► Subscribe
Argentina033059► Subscribe
Russian Federation2311922► Subscribe
South Korea20100061868► Subscribe
Canada2235443► Subscribe
MexicoPA03007942► Subscribe
Denmark0885961► Subscribe
Yugoslavia73503► Subscribe
South Korea100987311► 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: APIDRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
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
2017 00013Denmark► SubscribePRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
C/GB00/027United Kingdom► SubscribePRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
C/GB96/036United Kingdom► SubscribePRODUCT NAME: INSULIN LISPRO, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: CH 53290 19951123; CH 53553 19951123; UK EU/1/96/007/001 19960430; UK EU/1/96/007/002 19960430; UK EU/1/96/007/003 19960430
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Covington
Cipla
Cerilliant
McKinsey
Chinese Patent Office
Baxter
AstraZeneca
Merck

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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