Brimonidine tartrate - Generic Drug Details

What are the generic drug sources for brimonidine tartrate and what is the scope of patent protection?

Brimonidine tartrate is the generic ingredient in nine branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Akorn, Apotex, Bausch And Lomb, Indoco, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Bausch And Lomb Inc, Alcon Labs Inc, and Apotex Inc, and is included in twenty 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 twenty-four patent family members in thirty-two countries.

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

Summary for brimonidine tartrate

International Patents:	224
US Patents:	34
Tradenames:	9
Applicants:	13
NDAs:	20
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	51
Patent Applications:	2,449
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
What excipients (inactive ingredients) are in brimonidine tartrate?	brimonidine tartrate excipients list
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
Visus Therapeutics	Phase 3
Optall Vision	Phase 1

See all brimonidine tartrate clinical trials

Generic filers with 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

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

Anatomical Therapeutic Chemical (ATC) Classes for brimonidine tartrate

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUMIFY	Ophthalmic Solution	brimonidine tartrate	0.025%	208144	1	2021-07-12
MIRVASO	Topical Gel	brimonidine tartrate	0.33%	204708	1	2014-12-15
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.1%	021770	1	2006-12-20
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.15%	021262	1	2006-11-03

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 P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005		RX	Yes	Yes					Y
Somerset Theraps Llc	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208992-001	Mar 11, 2019	AT	RX	No	No
Bausch And Lomb	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	076260-001	May 28, 2003	AT	RX	No	Yes
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005		RX	Yes	Yes
Allergan	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	AB	RX	Yes	Yes
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes

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

International Patents for brimonidine tartrate

Country	Patent Number	Title	Estimated Expiration
China	101380321	Compounds, formulations, and methods for ameliorating telangiectasias
New Zealand	522610	Compositions containing therapeutically active components having enhanced solubility
Canada	2732521	COMPOSITIONS DE VASOCONSTRICTION, ET PROCEDES D'UTILISATION (VASOCONSTRICTION COMPOSITIONS AND METHODS OF USE)
Slovenia	2388007
Israel	151530
Norway	20024221

Supplementary Protection Certificates for brimonidine tartrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	C 2014 030	Romania		PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221
1631293	122014000080	Germany		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	C300683	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	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
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