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Last Updated: August 13, 2020

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Bromfenac sodium - Generic Drug Details

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What are the generic drug sources for bromfenac sodium and what is the scope of patent protection?

Bromfenac sodium is the generic ingredient in five branded drugs marketed by Bausch And Lomb Inc, Alembic Pharms Ltd, Amring Pharms, Apotex, Coastal Pharms, Gland Pharma Ltd, Hi Tech, Mylan, Vistapharm, Sun Pharma Global, and Bausch And Lomb, and is included in twelve NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bromfenac sodium has thirty patent family members in fourteen countries.

Five suppliers are listed for this compound.

Drug Prices for bromfenac sodium

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Recent Clinical Trials for bromfenac sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ministry of Health, ChinaN/A
Sun Yat-sen UniversityN/A
Federal University of São PauloPhase 4

See all bromfenac sodium clinical trials

Pharmacology for bromfenac sodium
Paragraph IV (Patent) Challenges for BROMFENAC SODIUM
Tradename Dosage Ingredient NDA Submissiondate
BROMSITE SOLUTION/DROPS;OPHTHALMIC bromfenac sodium 206911 2017-10-25
PROLENSA SOLUTION/DROPS;OPHTHALMIC bromfenac sodium 203168 2013-07-26

US Patents and Regulatory Information for bromfenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alembic Pharms Ltd BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 210560-001 Jun 21, 2019 AT2 RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 211029-001 Mar 17, 2020 AT2 RX No No   Start Trial   Start Trial   Start Trial
Apotex BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202435-001 Jun 19, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Hi Tech BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203395-001 Jan 22, 2014 AT2 RX No Yes   Start Trial   Start Trial   Start Trial
Bausch And Lomb Inc XIBROM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664-001 Mar 24, 2005 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for bromfenac sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 11C0031 France   Start Trial PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 C 2011 004 Romania   Start Trial 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 SPC/GB11/054 United Kingdom   Start Trial 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   Start Trial PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316 2011C/027 Belgium   Start Trial PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316 C300494 Netherlands   Start Trial PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 1190018-0 Sweden   Start Trial RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Boehringer Ingelheim
Colorcon
Mallinckrodt
Express Scripts

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