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BEPREVE Drug 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. One supplier is listed for this compound. Additional details are available on the bepotastine besilate profile page.
US ANDA Litigation and Generic Entry Outlook for Bepreve
Bepreve was eligible for patent challenges on September 8, 2013.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
There is one tentative approval for the generic drug (bepotastine besilate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for BEPREVE
| International Patents: | 11 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 5 |
| Patent Applications: | 15 |
| Drug Prices: | Drug price information for BEPREVE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BEPREVE |
| 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 |
| McCabe Vision Center | N/A |
| Minnesota Eye Consultants, P.A. | Phase 4 |
Pharmacology for BEPREVE
| Drug Class | Histamine-1 Receptor Antagonist |
Paragraph IV (Patent) Challenges for BEPREVE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BEPREVE | SOLUTION/DROPS;OPHTHALMIC | bepotastine besilate | 022288 | 2013-09-09 |
US Patents and Regulatory Information for BEPREVE
| 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bausch And Lomb Inc | BEPREVE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 022288-001 | Sep 8, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BEPREVE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69712784 | Start Trial |
| Japan | 3157118 | Start Trial |
| Austria | 528003 | Start Trial |
| China | 1293880 | Start Trial |
| South Korea | 101016595 | Start Trial |
| Japan | 2014169294 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9829409 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
