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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Queensland Health
Cantor Fitzgerald
Chubb
Covington
Healthtrust
Mallinckrodt
Johnson and Johnson
Deloitte

Generated: July 15, 2018

DrugPatentWatch Database Preview

Bromfenac sodium - Generic Drug Details

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What are the generic sources for bromfenac sodium and what is the scope of bromfenac sodium freedom to operate?

Bromfenac sodium
is the generic ingredient in five branded drugs marketed by Bausch And Lomb Inc, Amring Pharms, Apotex Inc, Coastal Pharms, Hi-tech Pharmacal, Paddock Llc, Sun Pharma Global, and Bausch And Lomb, and is included in nine NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bromfenac sodium has twenty-nine patent family members in fourteen countries.

Five suppliers are listed for this compound.
Summary for bromfenac sodium
Pharmacology for bromfenac sodium

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bausch And Lomb Inc XIBROM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664-001 Mar 24, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202620-001 Jun 23, 2014 AT2 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharma Global BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911-001 Apr 8, 2016 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

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Non-Orange Book US Patents for bromfenac sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,497,304 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for bromfenac sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/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
C0031 France ➤ Sign Up PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/11/692/001 DU 20110518; REGISTRATION NO/DATE AT EEC: EU/1/11/692/001 DU 20110518
90018-0 Sweden ➤ Sign Up RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
00494 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Deloitte
QuintilesIMS
Cantor Fitzgerald
US Department of Justice
AstraZeneca
Chinese Patent Office
McKinsey
Farmers Insurance

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 verifification 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.