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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Novartis
Cipla
Covington
Daiichi Sankyo
Boehringer Ingelheim
Argus Health
US Army
AstraZeneca

Generated: January 21, 2018

DrugPatentWatch Database Preview

PROLENSA Drug Profile

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When do Prolensa patents expire, and what generic 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-three patent family members in thirteen countries.

The generic ingredient in PROLENSA is bromfenac sodium. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for PROLENSA
International Patents:23
US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 55
Clinical Trials: 1
Patent Applications: 21
Drug Prices:see details
DailyMed Link:PROLENSA at DailyMed
Drug patent expirations by year for PROLENSA
Pharmacology for PROLENSA

US Patents and Regulatory Information for 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;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for PROLENSA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Ophthalmic Solution 0.07% ➤ Subscribe 7/26/2013

Non-Orange Book US Patents for 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
8,497,304 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for PROLENSA

Supplementary Protection Certificates for PROLENSA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00494 Netherlands ➤ Subscribe PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
C/GB11/054 United Kingdom ➤ Subscribe 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
C0031 France ➤ Subscribe PRODUCT 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
90018-0 Sweden ➤ Subscribe PRODUCT NAME: BROMFENAK; REG. NO/DATE: EU/1/11/692/001 20110518
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Deloitte
Chubb
Healthtrust
Novartis
Fuji
Daiichi Sankyo
Cipla

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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