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Generated: December 14, 2017

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Prasugrel hydrochloride - Generic Drug Details

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What are the generic drug sources for prasugrel hydrochloride and what is the scope of prasugrel hydrochloride patent protection?

Prasugrel hydrochloride
is the generic ingredient in two branded drugs marketed by Eli Lilly And Co, Aurobindo Pharma Ltd, Liberty Pharma Inc, Mylan Pharms Inc, and Panacea Biotec Ltd, and is included in five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Prasugrel hydrochloride has seventy patent family members in thirty-one countries and eight supplementary protection certificates in seven countries.

There are nineteen drug master file entries for prasugrel hydrochloride. Nine suppliers are listed for this compound.

Pharmacology for prasugrel hydrochloride

Medical Subject Heading (MeSH) Categories for prasugrel hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma LtdPRASUGRELprasugrel hydrochlorideTABLET;ORAL205888-002Oct 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Panacea Biotec LtdPRASUGRELprasugrel hydrochlorideTABLET;ORAL205897-001Oct 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Panacea Biotec LtdPRASUGRELprasugrel hydrochlorideTABLET;ORAL205897-002Oct 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Liberty Pharma IncPRASUGRELprasugrel hydrochlorideTABLET;ORAL205790-001Oct 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Eli Lilly And CoEFFIENTprasugrel hydrochlorideTABLET;ORAL022307-001Jul 10, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Eli Lilly And CoEFFIENTprasugrel hydrochlorideTABLET;ORAL022307-001Jul 10, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Eli Lilly And CoEFFIENTprasugrel hydrochlorideTABLET;ORAL022307-002Jul 10, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Pharms IncPRASUGRELprasugrel hydrochlorideTABLET;ORAL205927-002Jul 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Eli Lilly And CoEFFIENTprasugrel hydrochlorideTABLET;ORAL022307-002Jul 10, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Eli Lilly And CoEFFIENTprasugrel hydrochlorideTABLET;ORAL022307-001Jul 10, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: prasugrel hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And CoEFFIENTprasugrel hydrochlorideTABLET;ORAL022307-001Jul 10, 2009► Subscribe► Subscribe
Eli Lilly And CoEFFIENTprasugrel hydrochlorideTABLET;ORAL022307-002Jul 10, 2009► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: prasugrel hydrochloride

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
5,436,242 Tetrahydrothienopyridine derivatives, furo and pyrrolo analogs thereof for inhibiting blood platelet aggregation► 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: prasugrel hydrochloride

Country Document Number Estimated Expiration
Hong Kong1056118► Subscribe
Hong Kong1011017► Subscribe
China1041730► Subscribe
Mexico9205160► Subscribe
Czech Republic297570► Subscribe
Portugal1350511► Subscribe
Spain2122984► Subscribe
Luxembourg91589► Subscribe
Spain2311498► Subscribe
Austria407675► 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: PRASUGREL HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0397Netherlands► Subscribe300397, 20120909, EXPIRES: 20170908
C021/2009Ireland► SubscribeSPC021/2009: 20091119, EXPIRES: 20170908
00397Netherlands► SubscribePRODUCT NAME: PRASUGREL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225
0542411/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
C0031France► SubscribePRODUCT NAME: PRASUGREL; NAT. REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225; FIRST REGISTRATION: EU/1/08/503/001/-014 20090225
C/GB09/032United Kingdom► SubscribePRODUCT NAME: PRASUGREL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/08/503/001 20090225; UK EU/1/08/503/002 20090225; UK EU/1/08/503/003 20090225; UK EU/1/08/503/004 20090225
589Luxembourg► Subscribe91589, EXPIRES: 20170909
2009 00024Denmark► Subscribe
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Serving leading biopharmaceutical companies globally:

Teva
Julphar
Harvard Business School
Express Scripts
Medtronic
Chinese Patent Office
Cantor Fitzgerald
Novartis
Johnson and Johnson
McKinsey

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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