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Last Updated: April 25, 2024

MIRVASO Drug Patent Profile


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When do Mirvaso patents expire, and when can generic versions of Mirvaso launch?

Mirvaso is a drug marketed by Galderma Labs Lp and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-four patent family members in thirty-one countries.

The generic ingredient in MIRVASO is brimonidine tartrate. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mirvaso

A generic version of MIRVASO was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28th, 2003.

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Drug patent expirations by year for MIRVASO
Drug Prices for MIRVASO

See drug prices for MIRVASO

Recent Clinical Trials for MIRVASO

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

SponsorPhase
University of California, San FranciscoEarly Phase 1
Heinrich-Heine University, DuesseldorfPhase 2
GaldermaN/A

See all MIRVASO clinical trials

Pharmacology for MIRVASO
Paragraph IV (Patent) Challenges for MIRVASO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MIRVASO Topical Gel brimonidine tartrate 0.33% 204708 1 2014-12-15

US Patents and Regulatory Information for MIRVASO

MIRVASO is protected by twelve US patents.

Patents protecting MIRVASO

Brimonidine gel compositions and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds, formulations, and methods for treating or preventing rosacea
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Brimonidine gel composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Gel compositions and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds, formulations, and methods for ameliorating telangiectasis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for treating or preventing erythema
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Methods and compositions for safe and effective treatment of erythema
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial 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

International Patents for MIRVASO

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

Country Patent Number Title Estimated Expiration
South Africa 201402758 BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE ⤷  Try a Trial
Israel 225760 תכשירי ג'ל ברימונידי (Brimonidine gel compositions) ⤷  Try a Trial
Cyprus 1123393 ⤷  Try a Trial
European Patent Office 2444068 Composition de gel de brimonidine (Brimonidine gel composition) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MIRVASO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 C 2014 030 Romania ⤷  Try a Trial PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221
1631293 92462 Luxembourg ⤷  Try a Trial PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
1631293 C20140022 00150 Estonia ⤷  Try a Trial PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014
1631293 C01631293/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
>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.