BEPREVE Drug Patent Profile
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Which patents cover Bepreve, and when can generic versions of Bepreve launch?
Bepreve is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There is one patent 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. Six 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: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 7 |
| Patent Applications: | 138 |
| 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 at Marshall B. Ketchum University | Phase 4 |
| Southern California College of Optometry | 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
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | ⤷ 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 |
International Patents for BEPREVE
See the table below for patents covering BEPREVE around the world.
Make Better Decisions: Try a trial or see plans & pricing
ISSN: 2162-2639
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