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PROLENSA Drug Profile

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Prolensa is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in ten countries.

The generic ingredient in PROLENSA is bromfenac sodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

Summary for Tradename: PROLENSA

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: PROLENSA

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, 2013RXYes8,927,606► subscribe ► subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYes8,669,290► subscribeY ► subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYes8,871,813► subscribeY ► subscribe
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Paragraph IV activity for: PROLENSA

Drugname Dosage Strength RLD Submissiondate
bromfenac sodiumOphthalmic Solution0.07%Prolensa7/26/2013

Non-Orange Book Patents for Tradename: PROLENSA

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 Tradename: PROLENSA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2015170177► subscribe
Austria393627► subscribe
Spain2301964► 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: PROLENSA

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