Brimonidine tartrate - Generic Drug Details

✉ Email this page to a colleague

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

Brimonidine tartrate is the generic ingredient in ten branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Abbvie, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Indoco, Lupin Ltd, Micro Labs, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Bausch And Lomb Inc, Alcon Labs Inc, Florida, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in thirty-six 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:	10
Applicants:	22
NDAs:	36
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	153
Clinical Trials:	54
Patent Applications:	2,555
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
⤷ Sign Up	⤷ Sign Up	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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	215225-001	Mar 29, 2023	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	QOLIANA	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021764-001	May 22, 2006	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Florida	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	201949-001	Oct 4, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	⤷ Sign Up	⤷ Sign Up
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	⤷ Sign Up	⤷ Sign Up
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for brimonidine tartrate

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
France	2966366	COMPOSITION DE GEL DE BRIMONIDINE (Gel composition, useful for treating or preventing a skin disorder including e.g. rosacea, psoriasis, purpura, erythema of acne, and eczema, comprises methylparaben, preservatives, carbomer, and total polyol)	⤷ Sign Up
China	100569291		⤷ Sign Up
South Korea	20130002338	IMPROVED METHODS AND COMPOSITIONS FOR SAFE AND EFFECTIVE TREATMENT OF ERYTHEMA	⤷ Sign Up
Cyprus	1115727		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for brimonidine tartrate

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	2014/041	Ireland	⤷ Sign Up	PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	92462	Luxembourg	⤷ Sign Up	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	⤷ Sign Up	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	C 2014 030	Romania	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.