BROMSITE Drug Patent Profile
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Which patents cover Bromsite, and what generic alternatives are available?
Bromsite is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has six patent family members in six countries.
The generic ingredient in BROMSITE is bromfenac sodium. Ten suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bromsite
A generic version of BROMSITE was approved as bromfenac sodium by SENTISS on January 22nd, 2014.
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Questions you can ask:
- What is the 5 year forecast for BROMSITE?
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Summary for BROMSITE
International Patents: | 6 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 204 |
Patent Applications: | 171 |
Drug Prices: | Drug price information for BROMSITE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BROMSITE |
What excipients (inactive ingredients) are in BROMSITE? | BROMSITE excipients list |
DailyMed Link: | BROMSITE at DailyMed |
Pharmacology for BROMSITE
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Paragraph IV (Patent) Challenges for BROMSITE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BROMSITE | Ophthalmic Solution | bromfenac sodium | 0.075% | 206911 | 1 | 2017-10-25 |
US Patents and Regulatory Information for BROMSITE
BROMSITE is protected by one US patents.
Patents protecting BROMSITE
Non-steroidal anti-inflammatory ophthalmic compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | BROMSITE | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 206911-001 | Apr 8, 2016 | AB | 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 |
International Patents for BROMSITE
See the table below for patents covering BROMSITE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2403493 | COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STÉROÏDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2010102192 | ⤷ Sign Up | |
Portugal | 2403493 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BROMSITE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1586316 | 122011100019 | Germany | ⤷ Sign Up | PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
1586316 | 11C0031 | France | ⤷ Sign Up | PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
1586316 | 2011C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |