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Last Updated: March 28, 2024

MIRVASO Drug Patent Profile


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Which patents cover Mirvaso, 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-three 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. Fourteen 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

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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
Skin Laser & Surgery SpecialistsN/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
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
>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
European Patent Office 2481412 Composés, formulations et procédés pour traiter ou prévenir les troubles inflammatoires de la peau (Compounds, formulations, and methods for treating or preventing inflammatory skin disorders) ⤷  Try a Trial
Mexico 354697 COMPOSICIONES DE GEL DE BRIMONIDINA Y MÉTODOS DE USO. (BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE.) ⤷  Try a Trial
Denmark 1761266 ⤷  Try a Trial
Japan 6185536 ⤷  Try a Trial
Cyprus 1114372 ⤷  Try a Trial
Australia 2011231543 Improved methods and compositions for safe and effective treatment of erythema ⤷  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 191 5019-2014 Slovakia ⤷  Try a Trial PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
1631293 1490049-2 Sweden ⤷  Try a Trial PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
1631293 C300683 Netherlands ⤷  Try a Trial PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
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 300683 Netherlands ⤷  Try a Trial PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 2014/041 Ireland ⤷  Try a Trial PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
>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.