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Last Updated: January 30, 2023

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, Akorn, Alembic Pharms Ltd, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Rising, Sun Pharm, and Bausch And Lomb, and is included in thirteen 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.

Seven 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
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 PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 210560-001 Jun 21, 2019 AT2 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 bromfenac sodium

Country Patent Number Title Estimated Expiration
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
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.) See Plans and Pricing
Germany 122011100019 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bromfenac sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 1190018-0 Sweden See Plans and Pricing RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
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 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 132011901975261 Italy See Plans and Pricing 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.