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Last Updated: April 19, 2024

Brimonidine tartrate - Generic Drug Details

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What are the generic 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 one hundred and ninety-nine 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:	199
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
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
Somerset Theraps Llc	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208992-001	Mar 11, 2019	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	216361-001	Feb 16, 2024		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Parenteral	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	076372-001	Sep 10, 2004		DISCN	No	No	⤷ 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
Indoco	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	091691-001	Nov 18, 2014	AT	RX	No	No	⤷ 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
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	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
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
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	⤷ 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
Australia	2011250793		⤷ Try a Trial
Denmark	2444068		⤷ Try a Trial
European Patent Office	2515917	BRIMONIDINE POUR BLANCHIMENT DES YEUX (BRIMONIDINE FOR EYE WHITENING)	⤷ 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
China	101816793	Compounds, formulations, and methods for treating or preventing rosacea	⤷ Try a Trial
Taiwan	I287998		⤷ Try a Trial
Portugal	2815748		⤷ 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	122014000080	Germany	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 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	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
1631293	CR 2014 00031	Denmark	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221
1631293	1490049-2	Sweden	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
1631293	14C0056	France	⤷ Try a Trial	PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	C20140022 00150	Estonia	⤷ Try a Trial	PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.