Bepotastine besilate - Generic Drug Details
✉ Email this page to a colleague
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 | |||
Alembic | BEPOTASTINE BESILATE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 214588-001 | Apr 5, 2023 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
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 | ||
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 | 3631748 | ⤷ Sign Up | |
South Korea | 101016595 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2004011001 | ⤷ Sign Up | |
Spain | 2371340 | ⤷ Sign Up | |
Australia | 2003252746 | AQUEOUS LIQUID PREPARATIONS AND LIGHT-STABILIZED AQUEOUS LIQUID PREPARATIONS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.