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Generated: November 12, 2018

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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 eleven patents protecting this drug and one Paragraph IV challenge.

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

Supplementary Protection Certificates for MIRVASO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0056 France ➤ Sign Up PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
2014000080 Germany ➤ Sign Up PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
90049-2 Sweden ➤ Sign Up PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
14/041 Ireland ➤ Sign Up PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; 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:

Fish and Richardson
Chubb
Dow
UBS
Farmers Insurance
Baxter
Deloitte
Johnson and Johnson
Argus Health

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