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Last Updated: May 25, 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 freedom to operate?

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

See drug prices for bromfenac sodium

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
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 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

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 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up
Mexico 2016014404 PREPARACION LIQUIDA ACUOSA QUE CONTIENE ACIDO 2-AMINO-3-(BROMOBENZOIL) FENILACETICO. (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)P HENYLACETIC ACID.) ⤷  Sign Up
Mexico 2014004347 COMPOSICION OCULAR QUE CONTIENE BROMFENACO CON BIODISPONIBILIDAD INCREMENTADA. (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bromfenac sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 122011100019 Germany ⤷  Sign Up PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 C300494 Netherlands ⤷  Sign Up PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: 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.