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. Four 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: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 7 |
| Patent Applications: | 212 |
| 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Bausch And Lomb Inc | BEPREVE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 022288-001 | Sep 8, 2009 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BEPREVE
See the table below for patents covering BEPREVE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 9829409 | ⤷ Try a Trial | |
| South Korea | 101016595 | ⤷ Try a Trial | |
| China | 1098262 | ⤷ Try a Trial | |
| Japan | 3157117 | ⤷ Try a Trial | |
| Canada | 2275987 | SELS D'ADDITION ACIDES DE COMPOSE DE PIPERIDINE OPTIQUEMENT ACTIF ET PROCEDE DE PRODUCTION ASSOCIE (ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE COMPOUND AND PROCESS FOR PREPARING THE SAME) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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