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Serving leading biopharmaceutical companies globally:

Queensland Health
Covington
Colorcon
Express Scripts
Medtronic
Cipla
Accenture
US Department of Justice
Daiichi Sankyo
Julphar

Generated: December 12, 2017

DrugPatentWatch Database Preview

APIDRA Drug Profile

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Which patents cover Apidra, and when can generic versions of Apidra launch?

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

This drug has eighty-seven patent family members in thirty-nine countries and forty-six 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 APIDRA

US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 51
Drug Prices:see details
DailyMed Link:APIDRA at DailyMed
Drug patent expirations by year for APIDRA

Pharmacology for APIDRA

Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Sanofi Aventis UsAPIDRAinsulin glulisine recombinantINJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRAinsulin glulisine recombinantINJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-002Dec 20, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRAinsulin glulisine recombinantINJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRA SOLOSTARinsulin glulisine recombinantINJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAPIDRAinsulin glulisine recombinantINJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-002Dec 20, 2005RXYesYes► Subscribe► Subscribe► SubscribeYY► 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
Taiwan562806► Subscribe
Poland205465► Subscribe
Brazil9803708► Subscribe
South Africa200306637► Subscribe
Hong Kong1016616► Subscribe
Argentina096376► Subscribe
Netherlands300170► Subscribe
Austria283919► Subscribe
Peru09682002► Subscribe
Hungary228847► 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
2017000040Germany► SubscribePRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
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
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
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
60026Netherlands► SubscribePRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
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Serving leading biopharmaceutical companies globally:

UBS
US Army
Johnson and Johnson
Colorcon
Fish and Richardson
Moodys
Fuji
Mallinckrodt
McKesson
Chubb

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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