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Tolcapone - Generic Drug Details

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Tolcapone is the generic ingredient in two branded drugs marketed by Par Pharm Inc and Valeant Pharms Llc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for tolcapone. Two suppliers are listed for this compound.

Summary for Generic Name: tolcapone

Tradenames:2
Patents:0
Applicants:2
NDAs:2
Drug Master File Entries: see list4
Suppliers / Packaging: see list2
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: tolcapone

Clinical Trials for: tolcapone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Llc
TASMAR
tolcapone
TABLET;ORAL020697-001Jan 29, 1998RXYes<disabled><disabled>
Valeant Pharms Llc
TASMAR
tolcapone
TABLET;ORAL020697-002Jan 29, 1998DISCNNo<disabled><disabled>
Par Pharm Inc
TOLCAPONE
tolcapone
TABLET;ORAL204584-001Mar 26, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: tolcapone

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Llc
TASMAR
tolcapone
TABLET;ORAL020697-001Jan 29, 19985,236,952<disabled>
Valeant Pharms Llc
TASMAR
tolcapone
TABLET;ORAL020697-002Jan 29, 19985,236,952<disabled>
Valeant Pharms Llc
TASMAR
tolcapone
TABLET;ORAL020697-001Jan 29, 19985,476,875<disabled>
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