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Generated: August 21, 2018

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Brimonidine tartrate - Generic Drug Details

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What are the generic drug sources for brimonidine tartrate and what is the scope of brimonidine tartrate freedom to operate?

Brimonidine tartrate is the generic ingredient in eight branded drugs marketed by Galderma Labs Lp, Allergan, Akorn, Bausch And Lomb, Indoco Remedies, Sandoz Inc, Teva Parenteral, Bausch And Lomb Inc, and Novartis Pharms Corp, and is included in fifteen NDAs. There are thirty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate has two hundred and four patent family members in thirty-one countries.

There are eleven drug master file entries for brimonidine tartrate. Eight suppliers are listed for this compound. There are four tentative approvals for this compound.

Pharmacology for brimonidine tartrate
Medical Subject Heading (MeSH) Categories for brimonidine tartrate
Synonyms for brimonidine tartrate
(4,5-Bihydro-1H-imidazol-2-yl)quinoxalin-6-amine L-tartrate
(5-Bromo-quinoxalin-6-yl)-(4,5-dihydro-1h-imidazol-2-yl)-amine L-tartrate
109826-56-4
1400635-36-0
359B465
4S9CL2DY2H
5-bromo-6-(2-imidazolidinylideneamino) quinoxaline l-tartrate
5-bromo-6-(2-imidazolin-2-ylamino)quinoxaline tartrate
5-bromo-N-
5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine L-Tartrate
5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine tartrate
5-Bromo-N-(4,5-Dihydro-1H-Imidazol-2-yl)-6-Quinoxalinamine TaTRate
5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine (2R,3R)-2,3-dihydroxysuccinate
5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine; (2R,3R)-2,3-dihydroxybutanedioic acid
5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine; (2S,3S)-2,3-dihydroxybutanedioic acid
5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine(2R,3R)-2,3-dihydroxysuccinate
59803-98-4 (Parent)
59803-99-5
6-Quinoxalinamine, 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-, (R-(R*,R*))-2,3-dihydroxybutanedioate (1:1)
6-Quinoxalinamine, 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-, (S-(R*,R*))-2,3-dihydroxybutanedioate (1:1)
70359-46-5
79570-19-7
A19740
AB0021226
AC-3599
AC1L1GYC
AC1OCEPC
AC1Q59OR
ACT08633
AGN 190342-LF
AGN 190342LF
AGN-190342-LF
Aiphagan
Aiphagan P
AK-68418
AK142929
AKOS015895446
AKOS016845265
AKOS022175702
Alphagan
Alphagan (TN)
Alphagan Z
AN-12800
API0007067
API0007142
AS-12798
AS-18083
AX8282531
BC004062
BC208828
Brimonidine D-tartarate
Brimonidine D-tartrate
Brimonidine L-tartarate
Brimonidine L-Tartrate
brimonidine Purite
Brimonidine tartarate
brimonidine tartrate (1:1), (S-(R*,R*))-isomer
Brimonidine tartrate (JAN/USAN)
Brimonidine tartrate [USAN:JAN]
Brimonidine tartrate [USAN]
Brimonidine tartrateUK 14,304 tartrate
Brimonidinne tartrate
Brominide tartrate
C11H10BrN5.C4H6O6
C15H16BrN5O6
CCG-221278
CHEMBL2062257
CS-4496
CTK3J3327
D00ARM
D02076
DR002734
DTXSID20426066
EBD23481
FT-0082637
HMS3652B06
HY-B0659A
I06-0561
KB-42499
KS-00000K6V
KSC493G2P
L(+)-TARTARIC ACID; BRIMONIDINE
LS-177484
LS40084
MFCD07773072
MolPort-003-845-306
MolPort-016-638-379
MolPort-023-220-671
MolPort-035-395-833
N-(5-bromoquinoxalin-6-yl)imidazolidin-2-imine;(2R,3R)-2,3-dihydroxybutanedioic acid
Novadur
PubChem15967
Qoliana
RT-001413
S-8158
S4266
SCHEMBL265607
SCHEMBL34647
SCHEMBL34649
SNJ-2022
ST24046243
ST51052789
TL8006987
UK 14,304 (tartrate)
UK 14,304 tartrate
UK-14304-18
UK-1430418
UK14,304TARTRATE
UNII-4S9CL2DY2H
VA10431
W0014
Tentative approvals for BRIMONIDINE TARTRATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial0.1%SOLUTION; OPHTHALMIC
➤ Try a Free Trial➤ Try a Free Trial0.2%; 0.5%SOLUTION; OPHTHALMIC
➤ Try a Free Trial➤ Try a Free Trial0.2%; 0.5%SOLUTION; OPHTHALMIC

US Patents and Regulatory Information for brimonidine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ALPHAGAN brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp SIMBRINZA brimonidine tartrate; brinzolamide SUSPENSION/DROPS;OPHTHALMIC 204251-001 Apr 19, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sandoz Inc BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 078075-001 Jan 30, 2008 AT RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 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
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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Expired US Patents for brimonidine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ALPHAGAN brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ALPHAGAN brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for brimonidine tartrate

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
8,557,817 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders ➤ Try a Free Trial
8,586,586 Methods and compositions for treating or preventing erythema ➤ Try a Free Trial
8,993,571 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders ➤ Try a Free Trial
8,080,550 Anesthetic compositions and methods of use ➤ Try a Free Trial
8,283,350 Compositions and methods for reducing capillary permeability ➤ Try a Free Trial
8,338,421 Compositions and methods for reversing rebound hyperemia ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for brimonidine tartrate

Supplementary Protection Certificates for brimonidine tartrate

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
90049-2 Sweden ➤ Try a Free Trial PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
0140022 00150 Estonia ➤ Try a Free Trial PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Chubb
Moodys
AstraZeneca
Boehringer Ingelheim
US Department of Justice
Chinese Patent Office
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.