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Last Updated: November 2, 2024

Bepotastine besilate - Generic Drug Details


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What are the generic sources for bepotastine besilate and what is the scope of patent protection?

Bepotastine besilate is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Mylan, Somerset Theraps Llc, and Bausch And Lomb Inc, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bepotastine besilate has eleven patent family members in eight countries.

There are seven drug master file entries for bepotastine besilate. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for bepotastine besilate

See drug prices for bepotastine besilate

Recent Clinical Trials for bepotastine besilate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Laboratorios PoenPhase 4
Laboratorios Sophia S.A de C.V.Phase 1
Dong-A ST Co., Ltd.N/A

See all bepotastine besilate clinical trials

Generic filers with tentative approvals for BEPOTASTINE BESILATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up1.5%SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bepotastine besilate
Paragraph IV (Patent) Challenges for BEPOTASTINE BESILATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BEPREVE Ophthalmic Solution bepotastine besilate 1.5% 022288 3 2013-09-09

US Patents and Regulatory Information for bepotastine besilate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 206066-001 Mar 5, 2019 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 206220-001 Mar 18, 2019 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 214588-001 Apr 5, 2023 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Somerset Theraps Llc BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 217770-001 Aug 14, 2024 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for bepotastine besilate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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