EFFIENT Drug Patent Profile

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. Ten 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 LUPIN LTD on January 9^th, 2023.

Summary for EFFIENT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	51
Patent Applications:	103
Formulation / Manufacturing:	see details
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

See drug prices for EFFIENT

See drug sales revenues for EFFIENT

Recent Clinical Trials for EFFIENT

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

Sponsor	Phase
Gangnam Severance Hospital	Phase 4
Severance Hospital	Phase 4
Ewha Woman's University Seoul 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

Anatomical Therapeutic Chemical (ATC) Classes for EFFIENT

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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

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
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	AB	RX	Yes	Yes

Expired US Patents for EFFIENT

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

International Patents for EFFIENT

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9205160	DERIVADOS DE TETRAHIDROTIENOPIRIDINA ANALOGOS FURO Y PIRROLO DE LOS MISMOS Y SU PREPARACION Y USOS PARA INHIBIR EL AGREGADO DE PLAQUETAS EN LA SANGRE.
Norway	923484
Hungary	0400644
Czech Republic	9202784
Germany	122009000045

Supplementary Protection Certificates for EFFIENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0542411	SPC021/2009	Ireland		SPC021/2009: 20091119, EXPIRES: 20170908
0542411	C300397	Netherlands		PRODUCT NAME: PRASUGREL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225
0542411	C00542411/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0542411	CA 2009 00024	Denmark
0542411	SPC/GB09/032	United Kingdom		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