You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Merck
Colorcon
AstraZeneca
Express Scripts
Mallinckrodt
Harvard Business School

Last Updated: August 8, 2020

DrugPatentWatch Database Preview

PROLENSA Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Which patents cover Prolensa, and when can generic versions of Prolensa launch?

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

This drug has twenty-four patent family members in thirteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Prolensa

A generic version of PROLENSA was approved as bromfenac sodium by HI TECH on January 22nd, 2014.

  Start Trial

Drug patent expirations by year for PROLENSA
Drug Prices for PROLENSA

See drug prices for PROLENSA

Drug Sales Revenue Trends for PROLENSA

See drug sales revenues for PROLENSA

Recent Clinical Trials for PROLENSA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
MDbackline, LLCPhase 2
Churchhill CommunicationsPhase 4
Statistics & Data CorporationPhase 4

See all PROLENSA clinical trials

Pharmacology for PROLENSA
Paragraph IV (Patent) Challenges for PROLENSA
Tradename Dosage Ingredient NDA Submissiondate
PROLENSA SOLUTION/DROPS;OPHTHALMIC bromfenac sodium 203168 2013-07-26

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   Start Trial   Start Trial   Start Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for PROLENSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 2011C/027 Belgium   Start Trial PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316 C300494 Netherlands   Start Trial PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 SPC/GB11/054 United Kingdom   Start Trial 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
1586316 1190018-0 Sweden   Start Trial RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316 122011100019 Germany   Start Trial PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 C 2011 004 Romania   Start Trial PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1586316 11C0031 France   Start Trial PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Harvard Business School
Johnson and Johnson
Mallinckrodt
Boehringer Ingelheim

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 verification 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.