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ONAPGO

NDA

APOMORPHINE HYDROCHLORIDE | N214056 | MDD US OPERATIONS LLC A SUB OF SUPERNUS PHARMACEUTICALS INC

1 strength0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

2028

Today

Feb. 3, 2028

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from US WorldMeds, LLC FDA-2019-P-6049 · 29 docket documents 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	Denied	US WorldMeds, LLC
Citizen Petition from US WorldMeds, LLC FDA-2015-P-2626 · 4 docket documents 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	Denied	US WorldMeds, LLC

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

Clinical Trials

37 trials from ClinicalTrials.gov, 1 active, 27 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Infusion of Apomorphine: Long-term Safety Study NCT02339064	Phase 3	Active	MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals	99	2015-02 → 2025-12
Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease NCT00955318	Phase 3	Completed	Kyowa Kirin Co., Ltd.	58	2009-07 → 2012-03
Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease NCT01683292	Phase 2	Completed	South Glasgow University Hospitals NHS Trust	29	2006-01 → 2007-05
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease NCT02469090	Phase 3	Completed	Sumitomo Pharma America, Inc.	141	2015-06-18 → 2017-12-11
Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500 NCT01058291	Phase 3	Completed	Kyowa Kirin Co., Ltd.	31	2010-01 → 2010-10
Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease NCT02940912	Phase 4	Completed	Clinique Beau Soleil	45	2017-01-31 → 2021-04-12
Extended Long-Term Safety Study of KW-6500 NCT01063621	Phase 3	Completed	Kyowa Kirin Co., Ltd.	27	2010-01 → 2012-03
Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.NCT00346827	Phase 2/3	Completed	Britannia Pharmaceuticals Ltd.	36	2006-07 → 2007-08
Blinking and Yawning in Epilepsy: The Role of Dopamine NCT01432821	N/A	Completed	Institut National de la Santé Et de la Recherche Médicale, France	31	2011-09 → 2014-12
A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients.NCT00145171	Phase 3	Completed	Mylan Bertek Pharmaceuticals	56	2001-02 → 2002-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1087.66

Highest Price

$1431.13

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
27505-0006-05ONAPGO 4.9MG/ML INJ,SOLN,CARTRIDGE,20ML	$1431.13	FSS	Supernus Pharmaceuticals, Inc.	09/14/2027
27505-0006-05ONAPGO 4.9MG/ML INJ,SOLN,CARTRIDGE,20ML	$1087.66	Big4	Supernus Pharmaceuticals, Inc.	09/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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

3 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2026	SUPPL -6	View Letter (PDF)
May 19, 2026	SUPPL -5	View Letter (PDF)
Feb 7, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 98MG/20ML (4.9MG/ML)

RLD

0 patents1 exclusivity▴

SOLUTION;SUBCUTANEOUS | Approved: Feb 3, 2025

Exclusivities (1)

Code	Date	Status
NP	Feb 3, 2028	Active