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Last Updated: January 30, 2023

Opicapone - Generic Drug Details


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

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

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

There is one drug master file entry for opicapone. One supplier is listed for this compound.

Summary for opicapone
International Patents:128
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 49
Clinical Trials: 20
Patent Applications: 235
What excipients (inactive ingredients) are in opicapone?opicapone excipients list
DailyMed Link:opicapone at DailyMed
Recent Clinical Trials for opicapone

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

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

See all opicapone clinical trials

Pharmacology for opicapone

US Patents and Regulatory Information for opicapone

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 212489-002 Apr 24, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Neurocrine ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Neurocrine ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

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

Supplementary Protection Certificates for opicapone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1907382 SPC/GB16/065 United Kingdom See Plans and Pricing 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 CR 2016 00061 Denmark See Plans and Pricing PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
1907382 PA2016036 Lithuania See Plans and Pricing PRODUCT NAME: OPIKAPONAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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