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Bromfenac sodium - Generic Drug Details

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

This ingredient has sixteen patent family members in twelve countries.

There are ten drug master file entries for bromfenac sodium. Nine suppliers are listed for this compound.

Summary for Generic Name: bromfenac sodium

Tradenames:5
Patents:7
Applicants:8
NDAs:9
Drug Master File Entries: see list10
Suppliers / Packaging: see list9
Therapeutic Class:Ophthalmic Agents
Drug Prices:see low prices

Pharmacology for Ingredient: bromfenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYes8,871,813► subscribeY ► subscribe
Bausch And Lomb Inc
BROMDAY
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC021664-002Oct 16, 2010DISCNNo► subscribe► subscribe
Apotex Inc
BROMFENAC SODIUM
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC202435-001Jun 19, 2014RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: bromfenac sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb Inc
XIBROM
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC021664-001Mar 24, 20054,910,225► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,497,304Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bromfenac sodium

Country Document Number Estimated Expiration
Denmark2403493► subscribe
Hong Kong1083468► subscribe
South Korea101059711► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BROMFENAC SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0031France► subscribePRODUCT 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
90018-0Sweden► subscribePRODUCT NAME: BROMFENAK; REG. NO/DATE: EU/1/11/692/001 20110518
00494Netherlands► subscribePRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
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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 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.

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