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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bepreve
A generic version of BEPREVE was approved as bepotastine besilate by APOTEX on March 5th, 2019.
Summary for BEPREVE
International Patents: | 11 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 72 |
Clinical Trials: | 7 |
Patent Applications: | 189 |
Drug Prices: | Drug price information for BEPREVE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BEPREVE |
What excipients (inactive ingredients) are in BEPREVE? | BEPREVE excipients list |
DailyMed Link: | BEPREVE at DailyMed |


Recent Clinical Trials for BEPREVE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Southern California College of Optometry | Phase 4 |
Southern California College of Optometry at Marshall B. Ketchum University | Phase 4 |
McCabe Vision Center | N/A |
Pharmacology for BEPREVE
Drug Class | Histamine-1 Receptor Antagonist |
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 |
Expired US Patents for BEPREVE
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 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |