Bepotastine Besilate Patent Expiration

Bepotastine Besilate was first introduced by Bausch And Lomb Inc in its drug Bepreve on Sep 8, 2009. 5 different companies have introduced drugs containing Bepotastine Besilate.


Bepotastine Besilate Patents

Given below is the list of patents protecting Bepotastine Besilate, 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
Bepreve US8784789 Aqueous liquid preparations and light-stabilized aqueous liquid preparations Jan 13, 2025 Bausch And Lomb Inc
Bepreve US8877168 Aqueous liquid preparations and light-stabilized aqueous liquid preparations Jul 30, 2023

(Expired)

Bausch And Lomb Inc
Bepreve US6780877 Acid addition salt of optically active piperidine compound and process for preparing the same Sep 19, 2019

(Expired)

Bausch And Lomb Inc



Bepotastine Besilate's Family Patents

Family Patents

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Bepotastine Besilate Generic API Manufacturers

Several generic applications have been filed for Bepotastine Besilate. The first generic version for Bepotastine Besilate was by Apotex Inc and was approved on Mar 5, 2019. And the latest generic version is by Somerset Therapeutics Llc and was approved on Aug 14, 2024.

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


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 1 generic for Bepotastine Besilate. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution/drops Prescription OPHTHALMIC AT Apr 5, 2023


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)





2. APOTEX

Apotex Inc has filed for 1 generic for Bepotastine Besilate. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution/drops Prescription OPHTHALMIC AT Mar 5, 2019


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





3. MYLAN

Mylan Pharmaceuticals Inc has filed for 1 generic for Bepotastine Besilate. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution/drops Prescription OPHTHALMIC AT Mar 18, 2019


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
San Carlos Mylan Pharmaceuticals Inc.
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Saint Albans Mylan Technologies, Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
India
Sinnar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hosur Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





4. SOMERSET THERAPS LLC

Somerset Therapeutics Llc has filed for 1 generic for Bepotastine Besilate. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution/drops Prescription OPHTHALMIC AT Aug 14, 2024