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EFFIENT Drug Profile

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Effient is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-seven patent family members in thirty-one countries.

The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

Summary for Tradename: EFFIENT

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: EFFIENT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co
EFFIENT
prasugrel hydrochloride
TABLET;ORAL022307-001Jul 10, 2009RXNo8,569,325*PED► subscribeY► subscribe
Eli Lilly And Co
EFFIENT
prasugrel hydrochloride
TABLET;ORAL022307-002Jul 10, 2009RXYes5,288,726*PED► subscribeY► subscribe
Eli Lilly And Co
EFFIENT
prasugrel hydrochloride
TABLET;ORAL022307-001Jul 10, 2009RXNo► subscribe► subscribe
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Paragraph IV activity for: EFFIENT

Drugname Dosage Strength RLD Submissiondate
prasugrel hydrochlorideTablets5 mg and 10 mgEffient7/10/2013

Non-Orange Book Patents for Tradename: EFFIENT

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 Tradename: EFFIENT

Country Document Number Estimated Expiration
Poland363183► subscribe
China100341506► subscribe
Canada2432644► 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: EFFIENT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0542411/01Switzerland► subscribeFORMER REPRESENTATIVE: BOHEST AG, CH
2009 00024Denmark► subscribe
C0031France► subscribePRODUCT NAME: PRASUGREL; NAT. REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225; FIRST REGISTRATION: EU/1/08/503/001/-014 20090225
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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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