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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.

Summary for brimonidine tartrate

International Patents:	204
US Patents:	34
Tradenames:	8
Applicants:	9
NDAs:	15
Drug Master File Entries:	11
Suppliers / Packagers:	8
Bulk Api Vendors:	101
Clinical Trials:	36
Patent Applications:	1,442
Drug Prices:	Drug price information 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

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
		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	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996		DISCN	Yes	No
Novartis Pharms Corp	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes			Y
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005		RX	Yes	Yes					Y
Allergan	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007		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
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013		RX	Yes	Yes

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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
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	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

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
8,557,817	Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
8,586,586	Methods and compositions for treating or preventing erythema
8,993,571	Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
8,080,550	Anesthetic compositions and methods of use
8,283,350	Compositions and methods for reducing capillary permeability
8,338,421	Compositions and methods for reversing rebound hyperemia

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International Patents for brimonidine tartrate

Country	Document Number	Estimated Expiration
Canada	2814952
Hungary	E033143
Hungary	S1400029
China	100569291
Argentina	083651
European Patent Office	2153819
World Intellectual Property Organization (WIPO)	2011075617

Supplementary Protection Certificates for brimonidine tartrate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
462	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
1 5019-2014	Slovakia		PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
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
14/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
2014000080	Germany		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
90049-2	Sweden		PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
0140022 00150	Estonia		PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014