Viewing data from:

ONGENTYS

NDA

OPICAPONE | N212489 | AMNEAL PHARMACEUTICALS LLC

2 strengths9 unique patents0 unique exclusivities

Patent Timeline

9 unique patents by expiration date

Expiring < 1yr (2)Active (7)Today

2027

2028

2029

2030

2031

2032

2033

Today

Apr. 2, 2029

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ongentys (2023)

Total Spending

$15.9M

Total Claims

16,716

Beneficiaries

3,270

Avg Cost/Unit

$23.22

Spending Trend

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

YoY Change:+7.5%

5yr CAGR:+5.5%

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

API Supply Chain5 active DMFs

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

BIAL-PORTELA AND CA SAOPICAPONE

DMF 321982017

BIAL PORTELA AND CA SAOPICAPONE

DMF 348382020

MSN LIFE SCIENCES PRIVATE LTDOPICAPONE

DMF 381102023

HETERO LABS LTDOPICAPONE

DMF 415662025

JIANGXI SYNERGY PHARMACEUTICAL CO LTDOPICAPONE

DMF 429882025

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

9 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 24, 2020

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8168793	Apr 2, 2029	—	Yes	Yes		—
8524746	Jul 14, 2029	—	—	—		—
8907099	May 12, 2027	—	Yes	—	—	—
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

9 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 24, 2020