Primidone Patent Expiration

Primidone was first introduced by Valeant Pharmaceuticals International in its drug Mysoline on Approved Prior to Jan 1, 1982. 12 different companies have introduced drugs containing Primidone.


About Veterinary Primidone

Primidone is used in drugs marketed by 2 different companies: Cronus Pharma Specialities India Private Ltd, Zoetis Inc.

Other drugs containing Primidone are: Mylepsin, primidone medi pets , Mylepsin tablets , Neurosyn tablets .

Primidone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Primidone:

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
Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor University Hospital, Clermont-Ferrand NA COMPLETED
(Apr 1, 2026)
PHASE3


Primidone Generic API Manufacturers

Several generic applications have been filed for Primidone. The first generic version for Primidone was by Watson Laboratories Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Carnegie Pharmaceuticals Llc and was approved on Jan 23, 2024.

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