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Last Updated: September 27, 2020

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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-three 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:123
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 25
Clinical Trials: 15
Patent Applications: 45
DailyMed Link:opicapone at DailyMed
Recent Clinical Trials for opicapone

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

SponsorPhase
Neurocrine BiosciencesPhase 1
Bial - Portela C S.A.Phase 4
Rabin Medical CenterPhase 3

See all opicapone clinical trials

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

Supplementary Protection Certificates for opicapone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1907382 CR 2016 00061 Denmark   Start Trial PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
1907382 16C1016 France   Start Trial PRODUCT NAME: OPICAPONE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/1066 20160628
1907382 PA2016036,C1907382 Lithuania   Start Trial PRODUCT NAME: OPIKAPONAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624
1907382 122016000095 Germany   Start Trial PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; 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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