Bepotastine besilate - Generic Drug Details
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What are the generic sources for bepotastine besilate and what is the scope of patent protection?
Bepotastine besilate
is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Mylan, Somerset Theraps Llc, and Bausch And Lomb Inc, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Bepotastine besilate has eleven patent family members in eight countries.
There are seven drug master file entries for bepotastine besilate. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for bepotastine besilate
International Patents: | 11 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 23 |
Patent Applications: | 265 |
Drug Prices: | Drug price trends 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 |
Generic filers with tentative approvals for BEPOTASTINE BESILATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 1.5% | SOLUTION;OPHTHALMIC |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
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 | |||
>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 bepotastine besilate
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 bepotastine besilate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | WO2004011001 | 水性液剤および光安定化された水性液剤 | ⤷ Sign Up |
Japan | 3631748 | ⤷ Sign Up | |
Spain | 2371340 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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