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PRASUGREL

ANDA

PRASUGREL HYDROCHLORIDE | A205927 | MYLAN PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: EFFIENT(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.2897

per ea

Lowest NADAC/Unit

$0.2857

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00378518693PRASUGREL 10 MG TABLET	$0.2897	EA	Generic	—	2026-06-17
00378518593PRASUGREL 5 MG TABLET	$0.2857	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 14, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 12, 2017

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 12, 2017