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Last Updated: March 29, 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

Identify potential brand extensions & 505(b)(2) entrants

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
Allergan ALPHAGAN brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996 DISCN Yes No ⤷  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
Alembic BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 215225-001 Mar 29, 2023 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

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

Supplementary Protection Certificates for brimonidine tartrate

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 122014000080 Germany ⤷  Try a Trial PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION 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
>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.