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Last Updated: April 22, 2024

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, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Rising, Sentiss, Sun Pharm, and Bausch And Lomb, and is included in sixteen 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.

Ten 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
Seoul National University HospitalPhase 2
Sun Yat-sen UniversityN/A
Ministry of Health, ChinaN/A

See all bromfenac sodium clinical trials

Pharmacology for bromfenac sodium
Anatomical Therapeutic Chemical (ATC) Classes for bromfenac sodium
Paragraph IV (Patent) Challenges for BROMFENAC SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BROMSITE Ophthalmic Solution bromfenac sodium 0.075% 206911 1 2017-10-25
PROLENSA Ophthalmic Solution bromfenac sodium 0.07% 203168 1 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 Inc XIBROM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664-001 Mar 24, 2005 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 211029-001 Mar 17, 2020 AT2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sentiss BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203395-001 Jan 22, 2014 AT2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bausch And Lomb Inc BROMDAY bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664-002 Oct 16, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 bromfenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb Inc XIBROM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664-001 Mar 24, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for bromfenac sodium

Country Patent Number Title Estimated Expiration
Portugal 1586316 ⤷  Try a Trial
Germany 602004013420 ⤷  Try a Trial
European Patent Office 2403493 COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STÉROÏDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS) ⤷  Try a Trial
Japan WO2004064828 2−アミノ−3−(4−ブロモベンゾイル)フェニル酢酸含有水性液剤 ⤷  Try a Trial
Canada 2852995 COMPOSITION OPHTALMIQUE QUI CONTIENT DU BROMFENAC PRESENTANT UNE BIODISPONIBILITE ACCRUE (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bromfenac sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 C300494 Netherlands ⤷  Try a 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 122011100019 Germany ⤷  Try a Trial PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 132011901975261 Italy ⤷  Try a Trial PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316 2011C/027 Belgium ⤷  Try a Trial PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316 C 2011 004 Romania ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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