Glyburide Patent Expiration

Glyburide was first introduced by Pfizer Inc in its drug Micronase on May 1, 1984. Other drugs containing Glyburide are Glyburide (Micronized), Glynase, Diabeta. 15 different companies have introduced drugs containing Glyburide.


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Clinical Trials

Recent Clinical Trials on Glyburide:

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
Glyburide and Metformin for Gestational Diabetes Mellitus (GDM) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2


Glyburide Generic API Manufacturers

Several generic applications have been filed for Glyburide. The first generic version for Glyburide was by Teva Pharmaceuticals Usa Inc and was approved on Aug 29, 1995. And the latest generic version is by Orient Pharma Co Ltd and was approved on Feb 22, 2019.

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