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Last Updated: May 30, 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 patent protection?

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-five 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 seventeen 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

Identify potential brand extensions & 505(b)(2) entrants

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

See all brimonidine tartrate clinical trials

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
1400635-36-0
2,3-Dihydroxybutanedioic acid--5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine (1/1)
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) quinoxalin-6-amine 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
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
A19740
AB0021226
AC-3599
ACT08633
AGN 190342-LF
AGN 190342LF
AGN-190342-LF
AGN-190342LF
AGN190342 tartrate
Aiphagan
Aiphagan P
AK-68418
AKOS015895446
AKOS016845265
Alphagan
Alphagan (TN)
Alphagan Z
Alphagan-P
API0007067
API0007142
AS-12798
AS-18083
AX8282531
BC004062
BCP28473
Brimonidine (tartrate)
Brimonidine (UK-14304 )
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
brimonidine-tartrate
Brimonidinne tartrate
Brominide tartrate
C11H10BrN5.C4H6O6
C15H16BrN5O6
CCG-221278
CHEMBL2062257
CS-4496
CTK3J3327
D02076
DTXSID20426066
DTXSID70911371
EBD23481
FT-0082637
HMS3413O18
HMS3652B06
HMS3677O18
HMS3715P18
HY-B0659A
KS-00000K6V
KSC493G2P
LS-177484
LS40084
N-(5-bromoquinoxalin-6-yl)imidazolidin-2-imine;(2R,3R)-2,3-dihydroxybutanedioic acid
Novadur
PubChem15967
Q27122452
Qoliana
RT-001413
S-8158
S4266
SCHEMBL265607
SCHEMBL34647
SCHEMBL34649
SNJ-2022
ST24046243
SW219492-1
UK 14,304 (tartrate)
UK 14,304 tartrate
UK-14304-18
UK-1430418
UK14304 tartrate
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
Novartis SIMBRINZA brimonidine tartrate; brinzolamide SUSPENSION/DROPS;OPHTHALMIC 204251-001 Apr 19, 2013 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 021262-001 Mar 16, 2001 AT RX Yes Yes   Start Trial   Start Trial 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 brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996   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 1490049-2 Sweden   Start Trial PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
1631293 C01631293/01 Switzerland   Start Trial PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
1631293 C300683 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Dow
Mallinckrodt
AstraZeneca
Medtronic

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 verification 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.