Difluprednate Patent Expiration

Difluprednate was first introduced by Sandoz Inc in its drug Durezol on Jun 23, 2008. 9 different companies have introduced drugs containing Difluprednate.


Difluprednate Patents

Given below is the list of patents protecting Difluprednate, 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
Durezol US6114319

(Pediatric)

Compositions containing difluprednate Nov 18, 2019

(Expired)

Sandoz
Durezol US6114319 Compositions containing difluprednate May 18, 2019

(Expired)

Sandoz



Difluprednate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Difluprednate:

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
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II University of California, San Francisco NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3


Difluprednate Generic API Manufacturers

Several generic applications have been filed for Difluprednate. The first generic version for Difluprednate was by Cipla Ltd and was approved on Aug 9, 2021. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Jan 26, 2026.

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