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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 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 May 28^th, 2003.

Summary for MIRVASO

International Patents:	114
US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	100
Clinical Trials:	11
Drug Prices:	Drug price information for MIRVASO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIRVASO
DailyMed Link:	MIRVASO at DailyMed

See drug prices for MIRVASO

Recent Clinical Trials for MIRVASO

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

Sponsor	Phase
University of California, San Francisco	Early Phase 1
Heinrich-Heine University, Duesseldorf	Phase 2
Galderma	N/A

See all MIRVASO clinical trials

Recent Litigation for MIRVASO

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

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			Y
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013		RX	Yes	Yes
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013		RX	Yes	Yes			Y
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013		RX	Yes	Yes			Y
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013		RX	Yes	Yes

International Patents for MIRVASO

Country	Patent Number	Estimated Expiration
Israel	251543
China	102743380
Poland	2444068
Japan	2013540143
Mexico	354697

Supplementary Protection Certificates for MIRVASO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	1490049-2	Sweden		PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	2014C/042	Belgium		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	C300683	Netherlands		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