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Last Updated: March 28, 2024

Tolcapone - Generic Drug Details


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What are the generic drug sources for tolcapone and what is the scope of patent protection?

Tolcapone is the generic ingredient in two branded drugs marketed by Bausch, Alvogen, Dr Reddys Labs Sa, Novast Labs, and Par Pharm Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for tolcapone. Three suppliers are listed for this compound.

Drug Prices for tolcapone

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Recent Clinical Trials for tolcapone

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SponsorPhase
University of Colorado, DenverPhase 2
University of California, San FranciscoEarly Phase 1
Lawrence Berkeley National LaboratoryEarly Phase 1

See all tolcapone clinical trials

Pharmacology for tolcapone

US Patents and Regulatory Information for tolcapone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm Inc TOLCAPONE tolcapone TABLET;ORAL 204584-001 Mar 26, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alvogen TOLCAPONE tolcapone TABLET;ORAL 207729-001 Jul 29, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch TASMAR tolcapone TABLET;ORAL 020697-002 Jan 29, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs TOLCAPONE tolcapone TABLET;ORAL 208937-001 Aug 7, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa TOLCAPONE tolcapone TABLET;ORAL 210095-001 Aug 1, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch TASMAR tolcapone TABLET;ORAL 020697-001 Jan 29, 1998 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for tolcapone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch TASMAR tolcapone TABLET;ORAL 020697-001 Jan 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Bausch TASMAR tolcapone TABLET;ORAL 020697-001 Jan 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Bausch TASMAR tolcapone TABLET;ORAL 020697-002 Jan 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Bausch TASMAR tolcapone TABLET;ORAL 020697-002 Jan 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for tolcapone

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Viatris Healthcare Limited Tasmar tolcapone EMEA/H/C/000132
Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors.Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa.Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.
Authorised no no no 1997-08-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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