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Last Updated: April 25, 2024

Brimonidine tartrate - Generic Drug Details

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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 nine branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Abbvie, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Indoco, Micro Labs, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Bausch And Lomb Inc, Alcon Labs Inc, Florida, Sentiss, and Upsher Smith Labs, and is included in thirty NDAs. There are twenty 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 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 is one tentative approval for this compound.

Summary for brimonidine tartrate

International Patents:	200
US Patents:	20
Tradenames:	9
Applicants:	19
NDAs:	30
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	153
Clinical Trials:	54
Patent Applications:	2,418
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

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
⤷ Try a Trial	⤷ Try a Trial	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

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
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch And Lomb	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	076260-001	May 28, 2003	AT	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	216909-001	Aug 1, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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	Y			⤷ Try a Trial
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		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	Y			⤷ 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
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996	⤷ 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
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	⤷ Try a Trial	⤷ Try a Trial
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996	⤷ 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
>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
Portugal	1761266		⤷ Try a Trial
Australia	2001273269		⤷ Try a Trial
South Africa	201402758	BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE	⤷ Try a Trial
Mexico	PA02008930	COMPOSICIONES QUE CONTIENEN COMPONENTES AGONISTAS ALFA-2-ADRENERGICOS. (COMPOSITIONS CONTAINING ALPHA-2-ADRENERGIC AGONIST COMPONENTS.)	⤷ Try a Trial
European Patent Office	2388007	Composition topique pour son utilisation dans le traitement d' une rougeur induite par une rosacée (Topical composition for use in the treatment of rosacea-induced redness)	⤷ Try a Trial
New Zealand	552325	The use of alpha 2 andrenoceptor agonists such as brimonidine for treating inflammatory skin disorders	⤷ Try a Trial
Spain	2424644		⤷ 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	C 2014 030	Romania	⤷ Try a Trial	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	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	C20140022 00150	Estonia	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014
1631293	C01631293/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
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	132014902284452	Italy	⤷ Try a Trial	PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221
1631293	2014C/042	Belgium	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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