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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Harvard Business School
Mallinckrodt
McKinsey
AstraZeneca

Last Updated: June 28, 2022

BEPREVE Drug Patent Profile


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When do Bepreve patents expire, and what generic alternatives are available?

Bepreve is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in eight countries.

The generic ingredient in BEPREVE is bepotastine besilate. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bepotastine besilate profile page.

Drug patent expirations by year for BEPREVE
Drug Prices for BEPREVE

See drug prices for BEPREVE

Recent Clinical Trials for BEPREVE

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

SponsorPhase
Southern California College of OptometryPhase 4
Southern California College of Optometry at Marshall B. Ketchum UniversityPhase 4
McCabe Vision CenterN/A

See all BEPREVE clinical trials

Pharmacology for BEPREVE
Paragraph IV (Patent) Challenges for BEPREVE
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 BEPREVE

BEPREVE is protected by two US patents.

Patents protecting BEPREVE

Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for BEPREVE

When does loss-of-exclusivity occur for BEPREVE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 03252746
Estimated Expiration: See Plans and Pricing

Austria

Patent: 8003
Estimated Expiration: See Plans and Pricing

China

Patent: 93880
Estimated Expiration: See Plans and Pricing

Patent: 12734
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 25884
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2004011001
Estimated Expiration: See Plans and Pricing

Patent: 31748
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1016595
Estimated Expiration: See Plans and Pricing

Patent: 050025137
Estimated Expiration: See Plans and Pricing

Spain

Patent: 71340
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BEPREVE around the world.

Country Patent Number Title Estimated Expiration
Malaysia 118016 ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE COMPOUND AND PROCESS FOR PREPARING THE SAME See Plans and Pricing
Japan 2012180360 ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE DERIVATIVE, AND METHOD FOR PRODUCING THE SAME See Plans and Pricing
Japan 2014169294 ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE DERIVATIVE AND MANUFACTURING METHOD THEREOF See Plans and Pricing
Austria 528003 See Plans and Pricing
Japan 2000159763 OPTICAL RESOLUTION OF PIPERIDINE DERIVATIVE USING ACYLAMINO ACID See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
McKinsey
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson

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