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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 ten patent family members in thirty countries.

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

Summary for MIRVASO

International Patents:	110
US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	100
Clinical Trials:	10
Drug Prices:	Drug price information for MIRVASO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIRVASO
Prior Art and Litigation Support	Order Prior Art and Litigation support for MIRVASO
DailyMed Link:	MIRVASO at DailyMed

Pharmacology for MIRVASO

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

Medical Subject Heading (MeSH) Categories for MIRVASO

Adrenergic alpha-2 Receptor Agonists

Antihypertensive Agents

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
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

Paragraph IV (Patent) Challenges for MIRVASO

Drugname	Dosage	Strength	RLD	Date
	Topical Gel	0.33%

International Patents for MIRVASO

Country	Patent Number	Estimated Expiration
Cyprus	1112242
Mexico	PA06013649
Portugal	2552449
Spain	2424644

Supplementary Protection Certificates for MIRVASO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	CR 2014 00031	Denmark		PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221
1631293	92462	Luxembourg		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	122014000080	Germany		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221