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Last Updated: October 7, 2024

PROLENSA Drug Patent 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. Thirteen 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
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Recent Clinical Trials for PROLENSA

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SponsorPhase
Wyse EyecarePhase 4
Sight Medical Doctors PLLCPhase 4
Ocular Therapeutix, Inc.Phase 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
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Patent Expiration: ⤷  Sign Up

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Patented Use: METHOD OF TREATING OCULAR INFLAMMATION

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Patented Use: METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE

Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Bromfenac bioavailability
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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
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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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 ⤷  Sign Up ⤷  Sign Up
>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
Germany 122011100019 ⤷  Sign Up
Mexico 2014004347 COMPOSICION OCULAR QUE CONTIENE BROMFENACO CON BIODISPONIBILIDAD INCREMENTADA. (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY.) ⤷  Sign Up
China 1700913 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROLENSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 SPC/GB11/054 United Kingdom ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 C 2011 004 Romania ⤷  Sign Up 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
>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.