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EFFIENT

NDA

PRASUGREL HYDROCHLORIDE | N022307 | COSETTE PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases 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	—
ELI LILLY AND COMPANY et al v. PAR PHARMACEUTICAL COMPANIES, INC. et al 2:2014cv00508 2 patentsANDA 20700prasugrel hydrochloride	D.N.J.	2014-01-24	Terminated 2014-06-26	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Effient (2023)

Total Spending

$1.1M

Total Claims

1,022

Beneficiaries

231

Avg Cost/Unit

$17.60

Spending Trend

$456K(2021)→$1.3M(2022)→$1.1M(2023)

YoY Change:+12.6%

5yr CAGR:+7.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

14 letters from Drugs@FDA

Date	Submission	Document
Dec 23, 2020	SUPPL -18	View Letter (PDF)
Mar 29, 2019	SUPPL -16	View Letter (PDF)
Mar 15, 2018	SUPPL -15	View Letter (PDF)
Jul 13, 2016	SUPPL -14	View Letter (PDF)
Jan 15, 2016	SUPPL -13	View Letter (PDF)
Jul 10, 2015	SUPPL -12	View Letter (PDF)
Nov 20, 2013	SUPPL -10	View Letter (PDF)
Oct 17, 2013	SUPPL -8	View Letter (PDF)
Dec 4, 2012	SUPPL -7	View Letter (PDF)
Mar 27, 2012	SUPPL -6	View Letter (PDF)
Sep 29, 2011	SUPPL -3	View Letter (PDF)
Dec 10, 2010	SUPPL -2	View Letter (PDF)
Apr 22, 2010	SUPPL -1	View Letter (PDF)
Jul 13, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 10, 2009

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 10, 2009