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APOKYN

NDA

APOMORPHINE HYDROCHLORIDE | N021264 | MDD US OPERATIONS LLC

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

3 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from US WorldMeds, LLC FDA-2019-P-6049 US WorldMeds, LLC filed this section 505(q) citizen petition on December 23, 2019, requesting that the FDA require any abbreviated new drug application (ANDA) for a generic version of APOKYN (apomorphine hydrochloride injection) seek approval of both the drug and device constituent parts of the comb	505(q)	2019-12-30	Open	US WorldMeds
Citizen Petition from US WorldMeds FDA-2019-P-3192 US WorldMeds, LLC filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any ANDA for a generic version of APOKYN (apomorphine hydrochloride injection), NDA 021264, to seek approval of both the drug and device constituent parts of	505(q)	2019-07-03	Open	US WorldMeds
Citizen Petition from US WorldMeds, LLC FDA-2015-P-2626 US WorldMeds, LLC, the licensee and exclusive distributor of APOKYN (apomorphine hydrochloride injection) for treating off-episodes in advanced Parkinson's disease, filed this citizen petition requesting that the FDA require all applicants seeking approval of apomorphine drug-device combination prod	505(q)	2015-07-24	Open	US WorldMeds

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Apokyn (2023)

Total Spending

$71.8M

Total Claims

2,318

Beneficiaries

581

Avg Cost/Unit

$524.84

Spending Trend

$97.8M(2019)→$107.3M(2020)→$91.7M(2021)→$69.1M(2022)→$71.8M(2023)

YoY Change:+17.1%

5yr CAGR:+9.2%

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

API Supply Chain3 active DMFs2 inactive

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

FRANCOPIA A EUROAPI COAPOMORPHINE HYDROCHLORIDE

DMF 128181998

MACFARLAN SMITH LTDAPOMORPHINE HYDROCHLORIDE

DMF 131881998

SUN PHARMACEUTICAL INDUSTRIES LTDAPOMORPHINE HYDROCHLORIDE USP

DMF 401982024

DIOSYNTH BVInactiveAPOMORPHINE HYDROCHLORIDE

DMF 89991991

LABORATOIRE AGUETTANT PARC SCIENTIFIC TONY GARNIER RUE ALEXANDER FLEMMINGInactiveAPOMORPHINE

DMF 93361991

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	SUPPL -25	View Letter (PDF)
Jun 23, 2022	SUPPL -21	View Letter (PDF)
May 6, 2022	SUPPL -22	View Letter (PDF)
May 5, 2020	SUPPL -18	View Letter (PDF)
Dec 4, 2019	SUPPL -17	View Letter (PDF)
May 22, 2019	SUPPL -16	View Letter (PDF)
Mar 20, 2017	SUPPL -14	View Letter (PDF)
Jul 28, 2014	SUPPL -10	View Letter (PDF)
Sep 7, 2010	SUPPL -9	View Letter (PDF)
Jan 6, 2009	SUPPL -5	View Letter (PDF)
Jan 6, 2009	SUPPL -3	View Letter (PDF)
Apr 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG/2ML (10MG/ML)

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Apr 20, 2004

No patent or exclusivity listings for this strength.

#002 — 30MG/3ML (10MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Apr 20, 2004