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Last Updated: June 25, 2021

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PROLENSA Drug Profile


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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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prolensa

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

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Drug patent expirations by year for PROLENSA
Drug Prices for PROLENSA

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Drug Sales Revenue Trends for PROLENSA

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Recent Clinical Trials for PROLENSA

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

SponsorPhase
Ocular Therapeutix, Inc.Phase 4
Sight Medical Doctors PLLCPhase 4
MDbackline, LLCPhase 2

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   Get Started Free   Get Started Free   Get Started Free
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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 C 2011 004 Romania   Get Started Free 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   Get Started Free PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 122011100019 Germany   Get Started Free PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 132011901975261 Italy   Get Started Free PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316 1190018-0 Sweden   Get Started Free RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316 SPC/GB11/054 United Kingdom   Get Started Free 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 C300494 Netherlands   Get Started Free PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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

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