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ONGENTYS Drug Patent Profile

Which patents cover Ongentys, and what generic alternatives are available?

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

This drug has one hundred and thirty-two 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:	132
US Patents:	9
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 eleven 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
Neurocrine	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No
Neurocrine	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes
Neurocrine	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes
Neurocrine	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No
Neurocrine	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No			Y
Neurocrine	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No

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
Japan	5517629
Ukraine	94054	ПОХІДНІ НІТРОКАТЕХОЛУ ЯК КОМТ-ІНГІБІТОРИ[ПРОИЗВОДНЫЕ НИТРОКАТЕХОЛА В КАЧЕСТВЕ КОМТ-ИНГИБИТОРОВ (NITROCATECHOL DERIVATIVES AS COMT INHIBITORS)
European Patent Office	2791134	COMPOSÉ CHIMIQUE UTILE EN TANT QU'INTERMÉDIAIRE POUR LA PRÉPARATION D'UN INHIBITEUR DE CATÉCHOL-O-MÉTHYLTRANSFÉRASE (CHEMICAL COMPOUND USEFUL AS INTERMEDIATE FOR PREPARING A CATECHOL-O-METHYLTRANSFERASE INHIBITOR)
Australia	2015352158	Medicaments for slowing parkinson's disease
Denmark	2413912
Brazil	PI1014865	"composição e formulação farmacêutica comreendendo derivados de nitrocatecol, e, método para fabricar uma composição ou formulação farmacêutica"

Supplementary Protection Certificates for ONGENTYS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1907382	PA2016036,C1907382	Lithuania		PRODUCT NAME: OPIKAPONAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382	PA2016036	Lithuania		PRODUCT NAME: OPIKAPONAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382	706	Finland
1907382	SPC/GB16/065	United Kingdom		CORRECTION OF GRANT INFORMATION ON SUPPLEMENTARY PROTECTION CERTIFICATE APPLICATIONSAPPLICANT: BIAL-PORTELA & CA, S.A.A AVENIDA DA SIDERURGIA, NACIONAL, 4745-457 S.MAMEDE DO CORONADO, PORTUGALPRODUCT: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREO FPRODUCT TYPE: MEDICINAL AUTHORISED: UK EU/1/15/1066/001/010 28 JUNE 2016 AUTHORISED EXTENSION: PATENT NO: EP1907382 TITLE: NITROCATECHOL DERIVATIVES AS COMT INHIBITORS SPC NO: SPC/GB16/065DATE GRANTED: 20 NOVEMBER 2020 MAXIMUM PERIOD EXPIRES ON: 27 JUNE 2031*CORRECTION OF GRANT DETAILS IN JOURNAL NUMBER 6865 DATED 16 DECEMBER 2020 TO INCLUDE MAXIMUM EXPIRY DETAILS AND UPDATED AUTHORISATION DETAILS.
1907382	300848	Netherlands		PRODUCT NAME: OPICAPON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1066 20160628
2481410	C02481410/01	Switzerland		PRODUCT NAME: OPICAPON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66547 26.04.2018