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Last Updated: March 19, 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-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
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
>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
Canada 2824612 COMPOSES, PREPARATIONS ET METHODES PERMETTANT DE TRAITER OU DE PREVENIR DES TROUBLES INFLAMMATOIRES CUTANES (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING INFLAMMATORY SKIN DISORDERS) ⤷  Try a Trial
Hungary E051833 ⤷  Try a Trial
South Korea 101257046 ⤷  Try a Trial
Spain 2647618 ⤷  Try a Trial
Slovenia 2444068 ⤷  Try a Trial
European Patent Office 1631293 COMPOSES, PREPARATIONS ET METHODES DE TRAITEMENT OU DE PREVENTION DE LA ROSACEE (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING ROSACEA) ⤷  Try a Trial
South Korea 20130101549 BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE ⤷  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 C01631293/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
1631293 14C0056 France ⤷  Try a Trial PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 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 122014000080 Germany ⤷  Try a Trial PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION 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 2014C/042 Belgium ⤷  Try a Trial PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221
1631293 132014902284452 Italy ⤷  Try a Trial PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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