OPICAPONE - Generic Drug Details

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What are the generic drug sources for opicapone and what is the scope of freedom to operate?

Opicapone is the generic ingredient in one branded drug marketed by Amneal and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There is one drug master file entry for opicapone. Two suppliers are listed for this compound.

Summary for OPICAPONE

International Patents:	123
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	20
Patent Applications:	160
What excipients (inactive ingredients) are in OPICAPONE?	OPICAPONE excipients list
DailyMed Link:	OPICAPONE at DailyMed

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

Generic Entry Date for OPICAPONE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 OPICAPONE

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

Sponsor	Phase
SK Chemicals Co., Ltd.	Phase 4
Neurocrine Biosciences	Phase 1
Bial - Portela C S.A.	Phase 4

See all OPICAPONE clinical trials

Pharmacology for OPICAPONE

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

Anatomical Therapeutic Chemical (ATC) Classes for OPICAPONE

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

US Patents and Regulatory Information for OPICAPONE

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Glossary

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

EU/EMA Drug Approvals for OPICAPONE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for OPICAPONE

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Country	Patent Number	Title	Estimated Expiration
Australia	2007346018	Dosage regimen for COMT inhibitors	⤷ Sign Up
Croatia	P20192133		⤷ Sign Up
Russian Federation	2009132188	РЕЖИМ ДОЗИРОВАНИЯ ИНГИБИТОРОВ КОМТ	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010114404		⤷ Sign Up
Turkey	201908590		⤷ Sign Up
Norway	2018013		⤷ Sign Up
Hungary	E047856		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OPICAPONE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1907382	122016000095	Germany	⤷ Sign Up	PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382	2016/054	Ireland	⤷ Sign Up	PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382	SPC/GB16/065	United Kingdom	⤷ Sign Up	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	16C1016	France	⤷ Sign Up	PRODUCT NAME: OPICAPONE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/1066 20160628
1907382	93327	Luxembourg	⤷ Sign Up	PRODUCT NAME: OPICAPONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1066 - ONGENTYS - OPICAPONE
1907382	706	Finland	⤷ Sign Up
1907382	132016000123029	Italy	⤷ Sign Up	PRODUCT NAME: OPICAPONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ONGENTYS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1066, 20160628
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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