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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Cantor Fitzgerald
Chubb
Express Scripts
Teva
Chinese Patent Office
Johnson and Johnson
QuintilesIMS

Generated: January 19, 2019

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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 ten 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.

Four suppliers are listed for this compound.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apotex Inc BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202620-001 Jun 23, 2014 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amring Pharms BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202030-001 Jan 9, 2013 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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Supplementary Protection Certificates for bromfenac sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/054 United Kingdom ➤ Try a Free 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
C0031 France ➤ Try a Free Trial 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
00494 Netherlands ➤ Try a Free Trial 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:

Dow
Fish and Richardson
Federal Trade Commission
Chubb
Deloitte
UBS
Julphar
Argus Health
Merck

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