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Last Updated: January 26, 2020

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MIRVASO Drug 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 fourteen patent family members in thirty countries.

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

US ANDA Litigation and Generic Entry Outlook for Mirvaso

A generic version of MIRVASO was approved as brimonidine tartrate by BAUSCH AND LOMB on January 26th, 2020.

  Start Trial

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

Recent Litigation for MIRVASO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P.2016-08-19
Galderma Laboratories LP v. Actavis Laboratories UT Inc.2015-03-12

See all MIRVASO litigation

Pharmacology for MIRVASO
Paragraph IV (Patent) Challenges for MIRVASO
Tradename Dosage Ingredient NDA Submissiondate
MIRVASO GEL;TOPICAL brimonidine tartrate 204708

US Patents and Regulatory Information for MIRVASO

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

Supplementary Protection Certificates for MIRVASO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 300683 Netherlands   Start 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 14C0056 France   Start Trial PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 2014/041 Ireland   Start Trial PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 1490049-2 Sweden   Start Trial PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
1631293 2014C/042 Belgium   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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