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Last Updated: November 30, 2023

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 nine branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Abbvie, Alembic, Apotex, Bausch And Lomb, Indoco, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Bausch And Lomb Inc, Alcon Labs Inc, Sentiss, Upsher Smith Labs, and Watson Labs Teva, and is included in twenty-seven NDAs. There are nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate has one hundred and ninety-eight patent family members in thirty-two countries.

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

Summary for brimonidine tartrate

International Patents:	198
US Patents:	19
Tradenames:	9
Applicants:	17
NDAs:	27
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	153
Clinical Trials:	54
Patent Applications:	2,520
Drug Prices:	Drug price trends 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

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

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
⤷ Try a Trial	⤷ Try a Trial	0.2%; 0.5%	SOLUTION; OPHTHALMIC
⤷ Try a Trial	⤷ Try a Trial	0.025%	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

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	078075-001	Jan 30, 2008	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	⤷ Try a Trial	⤷ Try a Trial
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	⤷ Try a Trial	⤷ Try a Trial
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	⤷ Try a Trial	⤷ Try a Trial
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	⤷ Try a Trial	⤷ Try a Trial
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for brimonidine tartrate

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Country	Patent Number	Title	Estimated Expiration
Poland	360707		⤷ Try a Trial
European Patent Office	2515917	BRIMONIDINE POUR BLANCHIMENT DES YEUX (BRIMONIDINE FOR EYE WHITENING)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011075617		⤷ Try a Trial
Hong Kong	1204996	用於治療或預防酒渣鼻的化合物、製劑和方法 (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING ROSACEA)	⤷ Try a Trial
Mexico	PA05014107	COMPUESTOS, FORMULACIONES Y METODOS PARA TRATAR O PREVENIR EL ACNE ROSACEA. (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING ROSACEA.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for brimonidine tartrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	132014902284452	Italy	⤷ Try a Trial	PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221
1631293	191 5019-2014	Slovakia	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
1631293	C300683	Netherlands	⤷ Try a 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
1631293	92462	Luxembourg	⤷ Try a Trial	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	1490049-2	Sweden	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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