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EFFIENT Drug Profile

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

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

This drug has thirty-two patent family members in twenty-six countries.

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.

Summary for EFFIENT

International Patents:	32
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	4
Bulk Api Vendors:	40
Clinical Trials:	42
Patent Applications:	17
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EFFIENT
DailyMed Link:	EFFIENT at DailyMed

Pharmacology for EFFIENT

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

Medical Subject Heading (MeSH) Categories for EFFIENT

Platelet Aggregation Inhibitors

Synonyms for EFFIENT

[5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxo-ethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate hydrochloride

[5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-6,7-dihydro-4H-thieno[3,2-c]pyridin-2-yl] acetate;hydrochloride

2-[2-(Acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)ethanone Hydrochloride

2-Acetoxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride

389574-19-0

5-((1RS)-2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno(3,2-c)pyridin-2-yl acetate hydrochloride

5-(2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride

574C190

AB0009955

AC-24004

ACM389574190

AK124410

AKOS022185568

AM20090719

AN-6869

CAS-389574-19-0

CHEMBL1201773

CP0133

CS-1785

CTK8E7134

D05597

DSSTox_CID_28993

DSSTox_GSID_49067

DSSTox_RID_83258

DTXSID1049067

EBD36213

Effient (TN)

Ethanone, 2-(2-(acetyloxy)-6,7-dihydrothieno(3,2-c)pyridin-5(4H)-yl)-1-cyclopropyl-2-(2-fluorophenyl)-, hydrochloride

Ethanone, 2-[2-(acetyloxy)-6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]-1-cyclopropyl-2-(2-fluorophenyl)-, hydrochloride (1:1)

FT-0656362

HY-15284A

JALHGCPDPSNJNY-UHFFFAOYSA-N

LY 640315

MFCD11867705

MolPort-006-170-137

NCGC00188690-01

NCGC00188690-02

Prasugrel (hydrochloride)

Prasugrel HCl

Prasugrel hydrochloride

Prasugrel hydrochloride (JAN/USAN)

Prasugrel Hydrochloride [USAN]

Prasugrel Hydrochloride(Discontinued)

Prasugren hydrochloride

PubChem23807

RT-015128

s4637

SC-20618

SCHEMBL246128

Tox21_113621

Tox21_113621_1

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
Eli Lilly And Co	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	AB	RX	Yes	No					Y
Eli Lilly And Co	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	AB	RX	Yes	Yes
Eli Lilly And Co	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	AB	RX	Yes	No
Eli Lilly And Co	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	AB	RX	Yes	Yes

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Expired US Patents for EFFIENT

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

Paragraph IV (Patent) Challenges for EFFIENT

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	5 mg and 10 mg		2013-07-10

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International Patents for EFFIENT

Country	Document Number	Estimated Expiration
Japan	4874482
Russian Federation	2262933
South Korea	100692934
Poland	206138

Supplementary Protection Certificates for EFFIENT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00397	Netherlands		PRODUCT NAME: PRASUGREL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225
C/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
C0031	France		PRODUCT NAME: PRASUGREL; NAT. REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225; FIRST REGISTRATION: EU/1/08/503/001/-014 20090225