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Last Updated: February 18, 2020

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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 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, Somerset Theraps Llc, Teva Parenteral, Bausch And Lomb Inc, and Novartis, and is included in sixteen NDAs. There are thirty-six 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 sixteen 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 five tentative approvals for this compound.

Drug Prices for brimonidine tartrate

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Drug Sales Revenue Trends for brimonidine tartrate

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Recent Clinical Trials for brimonidine tartrate

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SponsorPhase
Tulane UniversityPhase 4
Wendy LeePhase 4
Denver Health and Hospital AuthorityPhase 2

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Recent Litigation for brimonidine tartrate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P.2016-08-19
Galderma Laboratories LP v. Actavis Laboratories UT Inc.2015-03-12
AIP Acquisition LLC v. Level 3 Communications LLC2012-05-17

See all brimonidine tartrate litigation

Generic filers with tentative approvals for BRIMONIDINE TARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.15%SOLUTION/DROPS;OPHTHALMIC
  Start Trial  Start Trial0.1%SOLUTION; OPHTHALMIC
  Start Trial  Start Trial0.2%; 0.5%SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
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
AKOS015895446
AKOS016845265
AKOS022175702
Alphagan
Alphagan (TN)
Alphagan Z
Alphagan-P
AN-12800
API0007067
API0007142
AS-12798
AS-18083
AX8282531
BC004062
BC208828
BCP28473
Brimonidine (tartrate)
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
D02076
DTXSID20426066
EBD23481
FT-0082637
HMS3652B06
HMS3715P18
HY-B0659A
I06-0561
KB-42499
KS-00000K6V
KSC493G2P
LS-177484
LS40084
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
SW219492-1
TL8006987
UK 14,304 (tartrate)
UK 14,304 tartrate
UK-14304-18
UK-1430418
UNII-4S9CL2DY2H
VA10431
W0014
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
ALPHAGAN P SOLUTION/DROPS;OPHTHALMIC brimonidine tartrate 021770 2006-12-20
ALPHAGAN P SOLUTION/DROPS;OPHTHALMIC brimonidine tartrate 021262 2006-11-03
MIRVASO GEL;TOPICAL brimonidine tartrate 204708
ALPHAGAN SOLUTION/DROPS;OPHTHALMIC brimonidine tartrate 020613

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 COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Akorn BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 076439-001 Mar 14, 2006 AT RX No No   Start Trial   Start Trial   Start Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sandoz Inc BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 078075-001 Jan 30, 2008 AT RX No No   Start Trial   Start Trial   Start Trial
Allergan COMBIGAN brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 021398-001 Oct 30, 2007 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
Allergan ALPHAGAN brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996   Start Trial   Start Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005   Start Trial   Start Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001   Start Trial   Start Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001   Start Trial   Start Trial
Allergan ALPHAGAN brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996   Start Trial   Start Trial
Allergan ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for brimonidine tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 CR 2014 00031 Denmark   Start Trial PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221
1631293 300683 Netherlands   Start Trial PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 122014000080 Germany   Start Trial PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 2014/041 Ireland   Start Trial PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 2014C/042 Belgium   Start Trial PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221
1631293 132014902284452 Italy   Start Trial PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221
1631293 92462 Luxembourg   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Moodys
Johnson and Johnson
AstraZeneca
Express Scripts

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