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Last Updated: March 28, 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, 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 twenty-eight 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. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for brimonidine tartrate

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Drug Sales Revenue Trends for brimonidine tartrate

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Recent Clinical Trials for brimonidine tartrate

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SponsorPhase
Tulane UniversityPhase 4
Visus TherapeuticsPhase 3
Optall VisionPhase 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 Trial0.2%; 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
Medical Subject Heading (MeSH) Categories 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Sandoz BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 076254-001 Sep 16, 2003 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Apotex BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 078480-001 Dec 21, 2022 AB RX No No ⤷  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
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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 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 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

Country Patent Number Title Estimated Expiration
South Korea 20170018974 홍반의 유효하고 안전한 치료를 위한 개선된 방법 및 조성물 (IMPROVED METHODS AND COMPOSITIONS FOR SAFE AND EFFECTIVE TREATMENT OF ERYTHEMA) ⤷  Try a Trial
Mexico 354697 COMPOSICIONES DE GEL DE BRIMONIDINA Y MÉTODOS DE USO. (BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2010014552 ⤷  Try a Trial
South Korea 101707704 ⤷  Try a Trial
New Zealand 552325 The use of alpha 2 andrenoceptor agonists such as brimonidine for treating inflammatory skin disorders ⤷  Try a Trial
Canada 2578784 COMPOSITIONS CONTENANT DES COMPOSANTS AGONISTES ALPHA-2-ADRENERGIQUES (COMPOSITIONS CONTAINING ALPHA-2-ADRENERGIC AGONIST COMPONENTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for brimonidine tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 1490049-2 Sweden ⤷  Try a Trial PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 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 300683 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 2014/041 Ireland ⤷  Try a Trial PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
>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.