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Last Updated: October 26, 2021

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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-six 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:126
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 30
Clinical Trials: 20
Patent Applications: 151
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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Neurocrine ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Neurocrine ONGENTYS opicapone CAPSULE;ORAL 212489-001 Apr 24, 2020 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Neurocrine ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Neurocrine ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Neurocrine ONGENTYS opicapone CAPSULE;ORAL 212489-002 Apr 24, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Neurocrine ONGENTYS opicapone CAPSULE;ORAL 212489-001 Apr 24, 2020 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for opicapone

Country Patent Number Estimated Expiration
European Patent Office 3604299 ⤷  Free Forever Trial
Turkey 201908590 ⤷  Free Forever Trial
Canada 2616377 ⤷  Free Forever Trial
Canada 3088684 ⤷  Free Forever Trial
Russian Federation 2008101265 ⤷  Free Forever Trial
Cyprus 1116754 ⤷  Free Forever Trial
South Korea 20170043671 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for opicapone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1907382 271 50011-2016 Slovakia ⤷  Free Forever Trial PRODUCT NAME: OPIKAPON VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1066/001 - EU/1/15/1066/010 20160628
1907382 CR 2016 00061 Denmark ⤷  Free Forever Trial PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
1907382 122016000095 Germany ⤷  Free Forever Trial PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382 93327 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: OPICAPONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1066 - ONGENTYS - OPICAPONE
1907382 PA2016036,C1907382 Lithuania ⤷  Free Forever Trial PRODUCT NAME: OPIKAPONAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382 132016000123029 Italy ⤷  Free Forever Trial PRODUCT NAME: OPICAPONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ONGENTYS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1066, 20160628
1907382 2016/054 Ireland ⤷  Free Forever Trial PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1066 20160624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
McKesson
Mallinckrodt
Moodys
Dow

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