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Serving leading biopharmaceutical companies globally:

Novartis
Fish and Richardson
Deloitte
Boehringer Ingelheim
Covington
McKesson
Citi
Accenture
Colorcon
Cantor Fitzgerald

Generated: December 14, 2017

DrugPatentWatch Database Preview

APIDRA Drug Profile

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When do Apidra patents expire, 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
Czech Republic295964► Subscribe
South Korea20040011483► Subscribe
South Korea20100061868► Subscribe
Denmark1381385► Subscribe
Germany59812316► Subscribe
MontenegroP60808► Subscribe
Spain2393180► Subscribe
Ukraine65529► Subscribe
Peru09682002► Subscribe
Czech Republic9801934► 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
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
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
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
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
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
/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
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
0880Netherlands► SubscribePRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
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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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Cantor Fitzgerald
Boehringer Ingelheim
QuintilesIMS
Julphar
Moodys
Merck
Medtronic
US Department of Justice

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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