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 nine branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Abbvie, Alembic, Apotex, Bausch And Lomb, Indoco, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Bausch And Lomb Inc, Alcon Labs Inc, Sentiss, Upsher Smith Labs, and Watson Labs Teva, and is included in twenty-seven NDAs. There are nineteen 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-eight 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 are two tentative approvals for this compound.
Summary for brimonidine tartrate
International Patents: | 198 |
US Patents: | 19 |
Tradenames: | 9 |
Applicants: | 17 |
NDAs: | 27 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 153 |
Clinical Trials: | 54 |
Patent Applications: | 2,520 |
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 |
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 |
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 |
⤷ Try a Trial | ⤷ Try a Trial | 0.025% | 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
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
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 | ||||
Sandoz | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 078075-001 | Jan 30, 2008 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021770-001 | Aug 19, 2005 | AB | 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 | ⤷ 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
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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for brimonidine tartrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 360707 | ⤷ Try a Trial | |
European Patent Office | 2515917 | BRIMONIDINE POUR BLANCHIMENT DES YEUX (BRIMONIDINE FOR EYE WHITENING) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2011075617 | ⤷ Try a Trial | |
Hong Kong | 1204996 | 用於治療或預防酒渣鼻的化合物、製劑和方法 (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING ROSACEA) | ⤷ Try a Trial |
Mexico | PA05014107 | COMPUESTOS, FORMULACIONES Y METODOS PARA TRATAR O PREVENIR EL ACNE ROSACEA. (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING ROSACEA.) | ⤷ 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 | 132014902284452 | Italy | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221 |
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 | 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 | 1490049-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






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.