Tolcapone - Generic Drug Details

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

Tolcapone is the generic ingredient in two branded drugs marketed by Bausch, Alvogen, Dr Reddys Labs Sa, Endo Operations, and Novast Labs, 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.

Summary for tolcapone

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	25
Patent Applications:	6,407
Drug Prices:	Drug price trends for tolcapone
What excipients (inactive ingredients) are in tolcapone?	tolcapone excipients list
DailyMed Link:	tolcapone at DailyMed

See drug prices for tolcapone

Recent Clinical Trials for tolcapone

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

Sponsor	Phase
University of Colorado, Denver	Phase 2
University of California, San Francisco	Early Phase 1
Lawrence Berkeley National Laboratory	Early Phase 1

See all tolcapone clinical trials

Pharmacology for tolcapone

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

Anatomical Therapeutic Chemical (ATC) Classes for tolcapone

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

US Patents and Regulatory Information for tolcapone

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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
Dr Reddys Labs Sa	TOLCAPONE	tolcapone	TABLET;ORAL	210095-001	Aug 1, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	TOLCAPONE	tolcapone	TABLET;ORAL	208937-001	Aug 7, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-002	Jan 29, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alvogen	TOLCAPONE	tolcapone	TABLET;ORAL	207729-001	Jul 29, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

EU/EMA Drug Approvals for tolcapone

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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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