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PRASUGREL

ANDA

PRASUGREL HYDROCHLORIDE | A205913 | AMNEAL PHARMACEUTICALS OF NEW YORK LLC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ELI LILLY AND COMPANY et al v. ACCORD HEALTHCARE INC., USA et al 1:2014cv00389 3 patentsANDA 205987, 205913prasugrel hydrochloride	INSD	2014-03-12	Terminated 2018-05-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain15 active DMFs3 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDPRASUGREL HYDROCHLORIDE USP

DMF 253282011

MATRIX PHARMACORP PRIVATE LTDPRASUGREL HYDROCHLORIDE USP

DMF 256512011

ALEMBIC PHARMACEUTICALS LTDPRASUGREL HYDROCHLORIDE

DMF 258982012

RUYUAN HEC PHARM CO LTDPRASUGREL HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 267692012

LUPIN MANUFACTURING SOLUTIONS LTDPRASUGREL HYDROCHLORIDE USP

DMF 268792013

ALIVUS LIFE SCIENCES LTDPRASUGREL HYDROCHLORIDE

DMF 269252013

APITORIA PHARMA PRIVATE LTDPRASUGREL HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 269512013

MSN LABORATORIES PRIVATE LTDPRASUGREL HYDROCHLORIDE USP [ROUTE CODE - "PR"]

DMF 269582013

TAPI NL BVPRASUGREL HYDROCHLORIDE

DMF 270482013

SUN PHARMACEUTICAL INDUSTRIES LTDPRASUGREL HYDROCHLORIDE

DMF 271042013

HETERO DRUGS LTDPRASUGREL HYDROCHLORIDE

DMF 271192013

INTAS PHARMACEUTICALS LTDPRASUGREL HYDROCHLORIDE

DMF 272302013

UNICHEM LABORATORIES LTDPRASUGREL HYDROCHLORIDE USP

DMF 288602015

MEGAFINE PHARMA P LTDPRASUGREL HYDROCHLORIDE

DMF 296782015

MACLEODS PHARMACEUTICALS LTDPRASUGREL HYDROCHLORIDE

DMF 305652016

APOTEX PHARMACHEM INDIA PVT LTDInactivePRASUGREL HYDROCHLORIDE

DMF 270782013

MSN LABORATORIES PRIVATE LTDInactivePRASUGREL [ROUTE CODE - 'LP']

DMF 275712013

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactivePRASUGREL HYDROCHLORIDE

DMF 307642016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 19, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 19, 2018