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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 nine patent family members in thirty-one countries.

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

Summary for brimonidine tartrate

International Patents:	209
US Patents:	34
Tradenames:	8
Applicants:	9
NDAs:	15
Drug Master File Entries:	11
Suppliers / Packagers:	9
Bulk Api Vendors:	109
Clinical Trials:	43
Patent Applications:	1,466
Drug Prices:	Drug price information 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

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

Tentative approvals for BRIMONIDINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
		0.1%	SOLUTION; OPHTHALMIC
		0.2%; 0.5%	SOLUTION; OPHTHALMIC
		0.2%; 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	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007		RX	Yes	Yes			Y
Allergan	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007		RX	Yes	Yes			Y
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013		RX	Yes	Yes
Akorn	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	076439-001	Mar 14, 2006	AT	RX	No	No
Novartis Pharms Corp	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes			Y
Allergan	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007		RX	Yes	Yes			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	021262-001	Mar 16, 2001
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 P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001

International Patents for brimonidine tartrate

Country	Patent Number	Estimated Expiration
Spain	2424644
China	1460026
China	101816793
Canada	2530938
Japan	5747391
Denmark	2552449

Supplementary Protection Certificates for brimonidine tartrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	191 5019-2014	Slovakia		PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 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	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
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	1490049-2	Sweden		PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221