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AGRYLIN

NDA

ANAGRELIDE HYDROCHLORIDE | N020333 | TAKEDA PHARMACEUTICALS USA 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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Agrylin (2023)

Total Spending

$232K

Total Claims

207

Beneficiaries

Avg Cost/Unit

$8.17

Spending Trend

$396K(2019)→$1.9M(2020)→$553K(2021)→$336K(2022)→$232K(2023)

YoY Change:+0.0%

5yr CAGR:+0.9%

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

API Supply Chain8 active DMFs2 inactive

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

ASH STEVENS INCANAGRELIDE HYDROCHLORIDE MONOHYDRATE

DMF 159712002

CIPLA LTDANAGRELIDE HYDROCHLORIDE MONOHYDRATE USP

DMF 160242002

CHEMWERTH INCANAGRELIDE HYDROCHLORIDE MONOHYDRATE

DMF 164402003

ZYDUS LIFESCIENCES LTDANAGRELIDE HYDROCHLORIDE USP

DMF 165312003

OLPHA ASANAGRELIDE HYDROCHLORIDE

DMF 170412003

TORRENT PHARMACEUTICALS LTDANAGRELIDE HYDROCHLORIDE USP

DMF 294752015

MICRO LABS LTDANAGRELIDE HYDROCHLORIDE USP

DMF 371802022

PIRAMAL PHARMA LTDANAGRELIDE HYDROCHLORIDE MONOHYDRATE

DMF 381812023

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPAInactiveANAGRELIDE HYDROCHLORIDE

DMF 169692003

CHEMISCH PHARMAZEUTISCHES LABOR ROLF SACHSE GMBHInactiveANAGRELIDE HYDROCHLORIDE

DMF 182402005

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Oct 14, 2021	SUPPL -27	View Letter (PDF)
Mar 3, 2020	SUPPL -26	View Letter (PDF)
Dec 21, 2018	SUPPL -25	View Letter (PDF)
Mar 28, 2018	SUPPL -24	View Letter (PDF)
Jul 15, 2015	SUPPL -23	View Letter (PDF)
Nov 3, 2014	SUPPL -22	View Letter (PDF)
Feb 11, 2014	SUPPL -21	View Letter (PDF)
Jul 19, 2013	SUPPL -20	View Letter (PDF)
Nov 28, 2011	SUPPL -19	View Letter (PDF)
Feb 4, 2011	SUPPL -17	View Letter (PDF)
Jul 2, 2010	SUPPL -16	View Letter (PDF)
Jul 17, 2009	SUPPL -15	View Letter (PDF)
Jun 20, 2008	SUPPL -13	View Letter (PDF)
Dec 30, 2004	SUPPL -10	View Letter (PDF)
Dec 10, 2004	SUPPL -9	View Letter (PDF)
Dec 10, 2004	SUPPL -8	View Letter (PDF)
Dec 16, 1998	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 0.5MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 14, 1997

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 14, 1997