DrugPatentWatch Database Preview

Brimonidine tartrate - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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.

Summary for brimonidine tartrate

International Patents:	216
US Patents:	36
Tradenames:	8
Applicants:	10
NDAs:	16
Drug Master File Entries:	11
Suppliers / Packagers:	8
Bulk Api Vendors:	117
Clinical Trials:	45
Patent Applications:	1,610
Drug Prices:	Drug price trends for brimonidine tartrate
Drug Sales Revenues:	Drug sales revenues for brimonidine tartrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brimonidine tartrate
DailyMed Link:	brimonidine tartrate at DailyMed

See drug prices for brimonidine tartrate

See drug sales revenues for brimonidine tartrate

Recent Clinical Trials for brimonidine tartrate

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

Sponsor	Phase
Tulane University	Phase 4
Wendy Lee	Phase 4
Denver Health and Hospital Authority	Phase 2

See all brimonidine tartrate clinical trials

Recent Litigation for brimonidine tartrate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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 LLC	2012-05-17

See all brimonidine tartrate litigation

Generic filers with tentative approvals for BRIMONIDINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
		0.15%	SOLUTION/DROPS;OPHTHALMIC
		0.1%	SOLUTION; OPHTHALMIC
		0.2%; 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

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for brimonidine tartrate

Adrenergic alpha-2 Receptor Agonists

Antihypertensive Agents

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			Y
Akorn	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	076439-001	Mar 14, 2006	AT	RX	No	No
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005		RX	Yes	Yes					Y
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	AT	RX	Yes	Yes					Y
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005		RX	Yes	Yes					Y
Sandoz Inc	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	078075-001	Jan 30, 2008	AT	RX	No	No
Allergan	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007		RX	Yes	Yes			Y		Y

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
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001

International Patents for brimonidine tartrate

Country	Patent Number	Estimated Expiration
Japan	2008231122
South Africa	200207413
Argentina	033539
Canada	2505836
European Patent Office	2696874
World Intellectual Property Organization (WIPO)	0205822
Australia	2005247467

Supplementary Protection Certificates for brimonidine tartrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	CR 2014 00031	Denmark		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		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		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	2014C/042	Belgium		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		PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221
1631293	92462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225