Methimazole Patent Expiration

Methimazole was first introduced by King Pharmaceuticals Inc in its drug Tapazole on Approved Prior to Jan 1, 1982. 12 different companies have introduced drugs containing Methimazole.


About Veterinary Methimazole

Methimazole is used in drugs marketed by 3 different companies: Virbac Ah Inc, Dechra Veterinary Products Llc, Felix Pharmaceuticals Pvt Ltd.

Other drugs containing Methimazole are: Felanorm , Methimazole oral solution , Methimazole coated tablets , Felimazole .

Methimazole Petitions

Details of Methimazole's suitability petitions are listed below.

Petitioner Action Date of Action Description
Suitability Petitions
Ceva Santé Animale Approved
Mizner Bioscience, LLC Approved
Felix Pharmaceuticals Pvt. Ltd. Approved
e5 Pharma, LLC Denied
Norbrook Laboratories, Ltd. Approved
e5 Pharma, LLC. Approved 26 Aug, 2014 The generic product will differ in dosage form. The RLNAD is approved as a film-coated tablet. The proposed dosage form is a soft chewable tablet.

Methimazole's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Methimazole:

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
Methimazole in Patients With Progressive Glioblastoma Case Comprehensive Cancer Center NA SUSPENDED
(Aug 1, 2026)
PHASE2


Methimazole Generic API Manufacturers

Several generic applications have been filed for Methimazole. The first generic version for Methimazole was by Mylan Pharmaceuticals Inc and was approved on Mar 29, 2000. And the latest generic version is by Square Pharmaceuticals Plc and was approved on Feb 5, 2025.

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