EFFIENT Drug Patent Profile

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Which patents cover Effient, and what generic alternatives are available?

Effient is a drug marketed by Cosette and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Effient

A generic version of EFFIENT was approved as prasugrel hydrochloride by UNICHEM on August 28^th, 2023.

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Summary for EFFIENT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	51
Patent Applications:	1,363
Drug Prices:	Drug price information for EFFIENT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EFFIENT
What excipients (inactive ingredients) are in EFFIENT?	EFFIENT excipients list
DailyMed Link:	EFFIENT at DailyMed

Drug patent expirations by year for EFFIENT

Recent Clinical Trials for EFFIENT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Severance Hospital	Phase 4
Ewha Woman's University Seoul Hospital	Phase 4
International St. Mary's Hospital	Phase 4

See all EFFIENT clinical trials

Pharmacology for EFFIENT

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Paragraph IV (Patent) Challenges for EFFIENT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EFFIENT	Tablets	prasugrel hydrochloride	5 mg and 10 mg	022307	17	2013-07-10

US Patents and Regulatory Information for EFFIENT

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for EFFIENT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for EFFIENT

See the table below for patents covering EFFIENT around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20030065558		⤷ Sign Up
Czech Republic	287181	Tetrahydrothienopyridinové deriváty, jejich furo a pyrroloanalogy a jejich příprava a použití pro inhibici agregace krevních destiček (Tetrahydrothienopyridine derivatives, their furo and pyrrolo analogs, process of their preparation and pharmaceutical preparation)	⤷ Sign Up
Hungary	0301645		⤷ Sign Up
New Zealand	526540	Medicinal compositions containing aspirin and 2-acetoxy-5-(alpha-cyclopropylcarbonyl-2-flurobenzyl-4,5,6,7-tetrahydrothieno[3,2-c]pyridine useful in preventing thrombus or embolus diseases	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EFFIENT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0542411	SPC/GB09/032	United Kingdom	⤷ Sign Up	PRODUCT 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
0542411	C300397	Netherlands	⤷ Sign Up	PRODUCT NAME: PRASUGREL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225
0542411	91589	Luxembourg	⤷ Sign Up	91589, EXPIRES: 20170909
0542411	300397	Netherlands	⤷ Sign Up	300397, 20120909, EXPIRES: 20170908
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description