Viewing data from:

ONGENTYS

NDA

OPICAPONE | N212489 | AMNEAL PHARMACEUTICALS LLC

2 strengths9 unique patents0 unique exclusivities

Patent Timeline

9 unique patents by expiration date

Expired (1)Expiring < 1yr (3)Active (5)Today

2027

2028

2029

2030

2031

2032

2033

Today

Oct. 10, 2027

Jul. 14, 2029

May. 12, 2027

Jul. 26, 2026

Dec. 12, 2032

Oct. 10, 2027

Mar. 31, 2030

Mar. 31, 2030

Jan. 11, 2032

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

14 trials from ClinicalTrials.gov, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment NCT02101190	Phase 1	Completed	Bial - Portela C S.A.	16	2010-03 → 2010-05
Effect of Food on Opicapone NCT03116308	Phase 1	Completed	Bial - Portela C S.A.	28	2014-11-21 → 2015-01-28
Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone NCT02305316	Phase 1	Completed	Bial - Portela C S.A.	28	2014-02 → 2014-03
Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation NCT02305329	Phase 1	Completed	Bial - Portela C S.A.	56	2014-02 → 2014-04
Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067 NCT02071810	Phase 1	Completed	Bial - Portela C S.A.	34	2008-04 → 2008-09
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide NCT02169895	Phase 1	Completed	Bial - Portela C S.A.	16	2008-09 → 2008-11
Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers NCT02305277	Phase 1	Completed	Bial - Portela C S.A.	85	2014-03 → 2014-06
Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites NCT01515891	Phase 1	Completed	Bial - Portela C S.A.	4	2009-05 → 2010-09
Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects NCT02092168	Phase 1	Completed	Bial - Portela C S.A.	24	2008-10 → 2009-01
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide NCT02169466	Phase 1	Completed	Bial - Portela C S.A.	22	2009-01 → 2009-05

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$24.76

per ea

Lowest NADAC/Unit

$24.67

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64896040301ONGENTYS 50 MG CAPSULE	$24.76	EA	Brand	—	2026-10-21
64896040201ONGENTYS 25 MG CAPSULE	$24.67	EA	Brand	—	2026-01-05

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$487.91

Highest Price

$691.01

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64896-0402-01ONGENTYS 25MG CAP,ORAL	$487.91	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
64896-0402-01ONGENTYS 25MG CAP,ORAL	$691.01	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
64896-0403-01ONGENTYS 50MG CAP,ORAL	$489.68	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027
64896-0403-01ONGENTYS 50MG CAP,ORAL	$642.63	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027

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

Medicare Part D Spending

CMS annual spending data for Ongentys (2024)

Total Spending

$15.4M

Total Claims

16,686

Beneficiaries

3,276

Avg Cost/Unit

$21.75

Spending Trend

$545K(2020)→$6.7M(2021)→$11.9M(2022)→$15.9M(2023)→$15.4M(2024)

YoY Change:-6.3%

5yr CAGR:+2.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

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

HETERO LABS LTDOPICAPONE

DMF 415662025

JIANGXI SYNERGY PHARMACEUTICAL CO LTDOPICAPONE

DMF 429882025

BIAL-PORTELA AND CA SAOPICAPONE

DMF 321982017

BIAL PORTELA AND CA SAOPICAPONE

DMF 348382020

MSN LIFE SCIENCES PRIVATE LTDOPICAPONE

DMF 381102023

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2025	SUPPL -11	View Letter (PDF)
Feb 10, 2025	SUPPL -7	View Letter (PDF)
Apr 28, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG

RLD

11 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 24, 2020

Patents (11)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8168793	Oct 10, 2027	—	Yes	Yes		—
8524746	Jul 14, 2029	—	—	—		—
8907099	May 12, 2027	—	Yes	—	—	—
9550759	Jul 26, 2026	—	—	—		—
9550759	Jul 26, 2026	—	—	—		—
9550759	Jul 26, 2026	—	—	—		—
9630955	Dec 12, 2032	—	Yes	Yes		—
9745290	Oct 10, 2027	—	—	Yes		—
10071085	Mar 31, 2030	—	—	Yes	—	—
10583130	Mar 31, 2030	—	—	—		—
12129247	Jan 11, 2032	—	—	—		—

#002 — 50MG

RLD

11 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 24, 2020