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Last Updated: January 22, 2021

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MIRVASO Drug 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 nineteen 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. 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 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

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

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Pharmacology for MIRVASO
Paragraph IV (Patent) Challenges for MIRVASO
Tradename Dosage Ingredient NDA Submissiondate
MIRVASO GEL;TOPICAL brimonidine tartrate 204708 2014-12-15

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 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
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 RX Yes Yes   Start Trial   Start Trial Y   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 C01631293/01 Switzerland   Start Trial PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
1631293 92462 Luxembourg   Start 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 1490049-2 Sweden   Start Trial PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Medtronic

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