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Generated: August 21, 2018

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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.

Drug patent expirations by year for MIRVASO
Pharmacology for MIRVASO
Medical Subject Heading (MeSH) Categories for MIRVASO
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for MIRVASO
Drugname Dosage Strength RLD Date
➤ Subscribe Topical Gel 0.33% ➤ Subscribe ➤ Try a Free Trial

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 ➤ Try a Free Trial
8,586,586 Methods and compositions for treating or preventing erythema ➤ Try a Free Trial
8,557,817 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders ➤ Try a Free Trial
8,993,571 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for MIRVASO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
462 Luxembourg ➤ Try a Free 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
1 5019-2014 Slovakia ➤ Try a Free Trial PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
2014 00031 Denmark ➤ Try a Free Trial 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 ➤ Try a Free Trial PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
2014000080 Germany ➤ Try a Free Trial PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Moodys
Colorcon
Daiichi Sankyo
McKinsey
Healthtrust
Teva
Queensland Health
Baxter

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