Tolcapone Patent Expiration

Tolcapone is Used for managing symptoms of Parkinson's disease. It was first introduced by Bausch Health Us Llc in its drug Tasmar on Jan 29, 1998. 5 different companies have introduced drugs containing Tolcapone.


Tolcapone Patents

Given below is the list of patents protecting Tolcapone, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Tasmar US5476875 Catechol derivatives Dec 19, 2012

(Expired)

Bausch



Tolcapone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Tolcapone:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder University of Chicago NA COMPLETED
(Sep 1, 2026)
PHASE2
COMT Inhibition Among Individuals With Comorbid AUD/ADHD University of Colorado, Denver NA COMPLETED
(Apr 1, 2026)
PHASE2
Microbiome Derived Metabolism and Pharmacokinetics Rutgers, The State University of New Jersey NA COMPLETED
(Apr 1, 2026)
PHASE1


Tolcapone Generic API Manufacturers

Several generic applications have been filed for Tolcapone. The first generic version for Tolcapone was by Ph Health Ltd and was approved on Mar 26, 2015. And the latest generic version is by Alvogen Inc and was approved on Jul 29, 2020.

Given below is the list of companies who have filed for Tolcapone generic, along with the locations of their manufacturing plants worldwide.