BEPOTASTINE BESILATE Drug Patent Profile
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Which patents cover Bepotastine Besilate, and what generic alternatives are available?
Bepotastine Besilate is a drug marketed by Alembic, Apotex, Mylan, and Somerset Theraps Llc. and is included in four NDAs.
The generic ingredient in BEPOTASTINE BESILATE 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 Bepotastine Besilate
A generic version of BEPOTASTINE BESILATE was approved as bepotastine besilate by APOTEX on March 5th, 2019.
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Summary for BEPOTASTINE BESILATE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 23 |
| Patent Applications: | 138 |
| Drug Prices: | Drug price information for BEPOTASTINE BESILATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BEPOTASTINE BESILATE |
| What excipients (inactive ingredients) are in BEPOTASTINE BESILATE? | BEPOTASTINE BESILATE excipients list |
| DailyMed Link: | BEPOTASTINE BESILATE at DailyMed |
Recent Clinical Trials for BEPOTASTINE BESILATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Poen | Phase 4 |
| Laboratorios Sophia S.A de C.V. | Phase 1 |
| Dong-A ST Co., Ltd. | N/A |
Pharmacology for BEPOTASTINE BESILATE
| Drug Class | Histamine-1 Receptor Antagonist |
Paragraph IV (Patent) Challenges for BEPOTASTINE BESILATE
| 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 BEPOTASTINE BESILATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | BEPOTASTINE BESILATE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 214588-001 | Apr 5, 2023 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Somerset Theraps Llc | BEPOTASTINE BESILATE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 217770-001 | Aug 14, 2024 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | BEPOTASTINE BESILATE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 206066-001 | Mar 5, 2019 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | BEPOTASTINE BESILATE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 206220-001 | Mar 18, 2019 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
