Difluprednate Patent Expiration

Difluprednate was first introduced by Sandoz Inc in its drug Durezol on Jun 23, 2008. 5 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.

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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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 Epic Pharma Llc and was approved on May 14, 2024.

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


1. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Difluprednate. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

emulsion Prescription OPHTHALMIC AB Nov 17, 2021


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Paterson Amneal Pharmaceuticals, Llc
Hauppauge Amneal Pharmaceuticals of New York, LLC
East Hanover Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited





2. CIPLA

Cipla Ltd has filed for 1 generic for Difluprednate. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

emulsion Prescription OPHTHALMIC AB Aug 9, 2021


Manufacturing Plant Locations
New

Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.

Country City Firm Name
India
Vasco Da Gama Cipla Limited
Raigad Cipla Limited
Pithampur, District Dhar Cipla Limited
Bangalore Cipla Ltd.
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Mumbai Cipla Limited
Bengaluru Cipla Limited





3. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Difluprednate. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

emulsion Prescription OPHTHALMIC AB Nov 16, 2022





4. EPIC PHARMA LLC

Epic Pharma Llc has filed for 1 generic for Difluprednate. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

emulsion Prescription OPHTHALMIC AB May 14, 2024