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ONGENTYS Drug Patent Profile

When do Ongentys patents expire, and when can generic versions of Ongentys launch?

Ongentys is a drug marketed by Amneal and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and twenty-three patent family members in thirty-one countries.

The generic ingredient in ONGENTYS is opicapone. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the opicapone profile page.

DrugPatentWatch^® Generic Entry Outlook for Ongentys

Ongentys was eligible for patent challenges on April 24, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 12, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ONGENTYS

International Patents:	123
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	88
Drug Prices:	Drug price information for ONGENTYS
What excipients (inactive ingredients) are in ONGENTYS?	ONGENTYS excipients list
DailyMed Link:	ONGENTYS at DailyMed

See drug prices for ONGENTYS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ONGENTYS

NDA:

212489

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ONGENTYS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bial - Portela C S.A.	Phase 1
Bial - Portela C S.A.	Phase 4

See all ONGENTYS clinical trials

Pharmacology for ONGENTYS

Drug Class	Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ONGENTYS

N04BX	Other dopaminergic agents
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for ONGENTYS

ONGENTYS is protected by ten US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ONGENTYS

FDA Regulatory Exclusivity protecting ONGENTYS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No			Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes			Y	Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No			Y	Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes			Y

EU/EMA Drug Approvals for ONGENTYS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bial - Portela Cª, S.A.	Ongentys	opicapone	EMEA/H/C/002790 Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.	Authorised	no	no	no	2016-06-24
Bial Portela & Companhia S.A.	Ontilyv	opicapone	EMEA/H/C/005782 Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.	Authorised	no	no	no	2022-02-21

International Patents for ONGENTYS

When does loss-of-exclusivity occur for ONGENTYS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Brazil

Canada

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Poland

Portugal

Serbia

Slovenia

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ONGENTYS around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2017006953	MEDICAMENTOS PARA DISMINUIR LA EVOLUCION DE LA ENFERMEDAD DE PARKINSON. (MEDICAMENTS FOR SLOWING PARKINSON'S DISEASE.)
Portugal	1907382
Argentina	058439	DERIVADOS DE NITROCATECOL COMO INHIBIDORES DE COMT. PROCESOS DE OBTENCION Y COMPOSICIONES FARMACEUTICAS.
Lithuania	2481410

Supplementary Protection Certificates for ONGENTYS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1907382	132016000123029	Italy		PRODUCT NAME: OPICAPONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ONGENTYS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1066, 20160628
1907382	C 2016 044	Romania		PRODUCT NAME: OPICAPONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1066; DATE OF NATIONAL AUTHORISATION: 20160624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1066; DATE OF FIRST AUTHORISATION IN EEA: 20160624
1907382	CR 2016 00061	Denmark		PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
1907382	57/2016	Austria		PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 (MITTEILUNG) 20160628