Mirvaso Drug Patent Profile

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Which patents cover Mirvaso, and what generic alternatives are available?

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-four 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. Fifteen 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 28^th, 2003.

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Summary for Mirvaso

International Patents:	124
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	12
Patent Applications:	1,636
Drug Prices:	Drug price information for Mirvaso
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Mirvaso
What excipients (inactive ingredients) are in Mirvaso?	Mirvaso excipients list
DailyMed Link:	Mirvaso at DailyMed

Drug patent expirations by year 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

Pharmacology for Mirvaso

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

Anatomical Therapeutic Chemical (ATC) Classes 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

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Glossary

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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
>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.

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Country	Patent Number	Title	Estimated Expiration
South Africa	201402758	BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE	⤷ Try a Trial
Israel	225760	תכשירי ג'ל ברימונידי (Brimonidine gel compositions)	⤷ Try a Trial
Cyprus	1123393		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for Mirvaso

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	C 2014 030	Romania	⤷ Try a Trial	PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221
1631293	92462	Luxembourg	⤷ Try a 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	C20140022 00150	Estonia	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description