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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and six 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.

Summary for MIRVASO

International Patents:	106
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	101
Clinical Trials:	8
Patent Applications:	947
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

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

Synonyms for MIRVASO

(5-Bromo-quinoxalin-6-yl)-(4,5-dihydro-1H-imidazol-2-yl)-amine

(5-bromoquinoxalin-6-yl)-2-imidazolin-2-ylamine

[3H]-UK14304

[3H]brimonidine

5-brom-n-(4,5-dihydro-1h-imidazol-2-yl)chinoxalin-6-amin

5-bromanyl-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine

5-bromo-6-(2-imidazolidinylidenamino)quinoxaline

5-bromo-6-(2-imidazolin-2-ylamino) quinoxaline

5-Bromo-6-(2-imidazolin-2-ylamino)-quinoxaline

5-Bromo-6-(2-imidazolin-2-ylamino)quinoxaline

5-bromo-6-(imidazolidinylideneamino)quinoxaline

5-bromo-6-(imidazolin-2-ylamino)quinoxaline

5-Bromo-N-(2-imidazolin-2-yl)-6-quinoxalinamine

5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine

5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine

59803-98-4

6-Quinoxalinamine, 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-

6-Quinoxalinamine, 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)- (9CI)

6-Quinoxalinamine,5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-

6-Quinoxalinamine,5-dihydro-1H-imidazol-2-yl)-

70359-46-5 (tartrate[1:1])

803B984

A832477

AC-162

AC1L1DO5

AC1Q24IC

AC1Q26LW

AGN 190342

AGN-190342

AJ-78420

AK-35795

AKOS005267239

AN-6804

ANW-59812

ARONIS24406

B4132

BC215787

BDBM34572

BIDD:GT0649

brimonidina

brimonidine

Brimonidine (bioerodible, extended release)

Brimonidine (INN)

Brimonidine [INN:BAN]

brimonidinum

BRN 0751629

Bromoxidine

C-18323

C07886

C11H10BrN5

CAS-59803-98-4

CC-25204

CCG-205290

CHEBI:3175

CHEMBL844

cid_2435

CJ-16916

CPD000058355

CS-2892

CTK5B0525

D03ACG

D07540

D0AE3X

D0GD9D

DB00484

DR001107

DSSTox_CID_25221

DSSTox_GSID_45221

DSSTox_RID_80758

DTXSID3045221

E6GNX3HHTE

EN300-50880

EU-0101216

FT-0082636

FT-0630717

FT-0650586

GS-3236

GTPL520

GTPL5386

HE358175

HMS3259P09

HMS3263D14

HMS3266O03

HY-B0659

IMED608142799

KB-197165

KS-00000F2V

KS-000048KL

L000615

LK 14304-18

Lopac-U-104

Lopac0_001216

LP01216

LS-142950

Lumify

MCULE-4542695850

MFCD00153878

MLS000069370

MLS001076349

MolPort-003-959-841

MRF-0000657

NC00638

NCGC00016069-01

NCGC00016069-02

NCGC00016069-03

NCGC00016069-04

NCGC00016069-05

NCGC00016069-06

NCGC00016069-07

NCGC00016069-08

NCGC00016069-09

NCGC00016069-10

NCGC00016069-11

NCGC00016069-12

NCGC00016069-13

NCGC00023468-02

NCGC00023468-04

NCGC00023468-05

NCGC00023468-06

NCGC00023468-07

NCGC00261901-01

NSC-318825

NSC318825

Opera_ID_612

PDSP1_000640

PDSP2_000635

SAM002548958

SBB080815

SCHEMBL24670

SMR000058355

SR-01000000023

SR-01000000023-2

ST2406733

T6531398

TC-148557

Tocris-0425

Tox21_110299

Tox21_110299_1

Tox21_501216

TRA0032007

UK 14,304

UK 14,304-18

UK 14304

UK 14304-18

UK 14308

UK-14,304-18

UK-14,308

UK-14304

UK14,304

UK14304

UNII-E6GNX3HHTE

XYLJNLCSTIOKRM-UHFFFAOYSA-N

Z802671510

ZINC21303210

ZX-AS004769

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

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Paragraph IV (Patent) Challenges for MIRVASO

Drugname	Dosage	Strength	RLD	Date
	Topical Gel	0.33%

Non-Orange Book US Patents for MIRVASO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,838,563	Compounds, formulations, and methods for ameliorating telangiectasias
8,586,586	Methods and compositions for treating or preventing erythema
8,557,817	Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
8,993,571	Compounds, formulations, and methods for treating or preventing inflammatory skin disorders

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International Patents for MIRVASO

Country	Document Number	Estimated Expiration
Spain	2647618
Canada	2567401
San Marino	T201400156
Denmark	2552449
China	101816793

Supplementary Protection Certificates for MIRVASO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
462	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
1 5019-2014	Slovakia		PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
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
14/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
2014000080	Germany		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221