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Last Updated: August 10, 2020

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XIBROM Drug Profile

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Which patents cover Xibrom, and when can generic versions of Xibrom launch?

Xibrom is a drug marketed by Bausch And Lomb Inc and is included in one NDA.

The generic ingredient in XIBROM is bromfenac sodium. Five suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Xibrom

A generic version of XIBROM was approved as bromfenac sodium by HI TECH on January 22nd, 2014.

  Start Trial

Summary for XIBROM
US Patents:0
Applicants:1
NDAs:1
Bulk Api Vendors: 162
Clinical Trials: 9
Patent Applications: 2,683
DailyMed Link:XIBROM at DailyMed
Drug patent expirations by year for XIBROM
Recent Clinical Trials for XIBROM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
InSite VisionPhase 1/Phase 2
AllerganPhase 4
Frank A. Bucci, Jr., M.D.Phase 4

See all XIBROM clinical trials

US Patents and Regulatory Information for XIBROM

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   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for XIBROM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 2011C/027 Belgium   Start Trial PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316 132011901975261 Italy   Start Trial PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316 11C0031 France   Start Trial PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 SPC/GB11/054 United Kingdom   Start 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
1586316 C 2011 004 Romania   Start 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
1586316 C300494 Netherlands   Start Trial 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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Serving leading biopharmaceutical companies globally:

Moodys
Merck
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Boehringer Ingelheim
Harvard Business School
McKinsey

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