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Last Updated: August 15, 2022

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. Six 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 AKORN on January 22nd, 2014.

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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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Denmark 2403493 See Plans and Pricing
Spain 2586064 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2010102192 See Plans and Pricing
Canada 2753947 COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STEROIDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS) See Plans and Pricing
European Patent Office 2403493 COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STÉROÏDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS) See Plans and Pricing
Portugal 2403493 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BROMSITE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 2011C/027 Belgium See Plans and Pricing PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316 11C0031 France See Plans and Pricing PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 SPC/GB11/054 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316 C 2011 004 Romania See Plans and Pricing PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1586316 C300494 Netherlands See Plans and Pricing PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 122011100019 Germany See Plans and Pricing PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Boehringer Ingelheim
Dow
Mallinckrodt
Merck

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