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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Chinese Patent Office
Healthtrust
Novartis
AstraZeneca
Fish and Richardson
Moodys
Deloitte
US Army

Generated: October 24, 2017

DrugPatentWatch Database Preview

PROLENSA Drug Profile

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What is the patent landscape for Prolensa, and what generic Prolensa alternatives are available?

Prolensa is a drug marketed by Bausch And Lomb and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in thirteen countries and four supplementary protection certificates in four countries.

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

Summary for Tradename: PROLENSA

US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list44
Clinical Trials: see list1
Patent Applications: see list21
Drug Prices:see details
DailyMed Link:PROLENSA at DailyMed

Pharmacology for Tradename: PROLENSA

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;OPHTHALMIC203168-001Apr 5, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Bausch And Lomb
PROLENSA
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC203168-001Apr 5, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges 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
European Patent Office1586316► Subscribe
World Intellectual Property Organization (WIPO)2004064828► Subscribe
Portugal1586316► Subscribe
Austria393627► Subscribe
Spain2301964► Subscribe
China1700913► Subscribe
HungaryS1100022► Subscribe
Hong Kong1083468► Subscribe
Mexico2014004347► Subscribe
Japan4500261► 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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Teva
Medtronic
Queensland Health
Dow
Cerilliant
Baxter
Cipla
McKesson

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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