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Last Updated: July 18, 2024

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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Drug patent expirations by year for BROMSITE
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Pharmacology for BROMSITE
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
World Intellectual Property Organization (WIPO) 2010102192 ⤷  Sign Up
European Patent Office 2403493 COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STÉROÏDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS) ⤷  Sign Up
Portugal 2403493 ⤷  Sign Up
Denmark 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 SPC/GB11/054 United Kingdom ⤷  Sign Up PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
1586316 132011901975261 Italy ⤷  Sign Up PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.