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Last Updated: March 28, 2024

PROLENSA Drug Patent Profile


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When do Prolensa patents expire, 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. Ten 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 SENTISS 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
Wyse EyecarePhase 4
Ocular Therapeutix, Inc.Phase 4
Sight Medical Doctors PLLCPhase 4

See all PROLENSA clinical trials

Pharmacology for PROLENSA
Paragraph IV (Patent) Challenges for PROLENSA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROLENSA Ophthalmic Solution bromfenac sodium 0.07% 203168 1 2013-07-26

US Patents and Regulatory Information for PROLENSA

PROLENSA is protected by ten US patents.

Patents protecting PROLENSA

Bromfenac bioavailability
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING OCULAR INFLAMMATION

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Bromfenac bioavailability
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY

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

Expired US Patents for PROLENSA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PROLENSA

See the table below for patents covering PROLENSA around the world.

Country Patent Number Title Estimated Expiration
Mexico 2016014404 PREPARACION LIQUIDA ACUOSA QUE CONTIENE ACIDO 2-AMINO-3-(BROMOBENZOIL) FENILACETICO. (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)P HENYLACETIC ACID.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004064828 ⤷  Try a Trial
Hong Kong 1083468 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl) phenylacetic acid ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROLENSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 2011C/027 Belgium ⤷  Try a Trial PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316 1190018-0 Sweden ⤷  Try a Trial RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316 11C0031 France ⤷  Try a 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

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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 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.