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Serving 500+ biopharmaceutical companies globally:

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Generated: June 24, 2017

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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 Coastal Pharms, Sun Pharma Global, Apotex Inc, Amring Pharms, Paddock Llc, Bausch And Lomb Inc, Bausch And Lomb, and Hi-tech Pharmacal, 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-four patent family members in fourteen 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:10
Applicants:8
NDAs:9
Drug Master File Entries: see list10
Suppliers / Packagers: see list9
Bulk Api Vendors: see list42
Clinical Trials: see list2,376
Patent Applications: see list23
Therapeutic Class:Ophthalmic Agents
Drug Prices:see low prices
DailyMed Link:bromfenac sodium at DailyMed

Pharmacology for Ingredient: bromfenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Paddock Llc
BROMFENAC SODIUM
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC201941-001Feb 10, 2015AT1RXNoNo► Subscribe► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes8,669,290► SubscribeY ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes9,561,277► Subscribe ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes8,129,431► SubscribeYY ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes9,517,220► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: bromfenac sodium

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
Spain2301964► Subscribe
World Intellectual Property Organization (WIPO)2004064828► Subscribe
South Korea101059711► Subscribe
HungaryS1100022► Subscribe
Canada2852995► 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
C/GB11/054United Kingdom► SubscribePRODUCT 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
90018-0Sweden► SubscribePRODUCT NAME: BROMFENAK; REG. NO/DATE: EU/1/11/692/001 20110518
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
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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Fuji
Daiichi Sankyo
McKesson
Harvard Business School
Merck
Cipla
Johnson and Johnson
Baxter
US Department of Justice

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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