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Brimonidine tartrate - Generic Drug Details
What are the generic drug sources for brimonidine tartrate and what is the scope of brimonidine tartrate patent protection?
Brimonidine tartrate
is the generic ingredient in eight branded drugs marketed by Galderma Labs Lp, Allergan, Akorn, Bausch And Lomb, Indoco Remedies, Sandoz Inc, Teva Parenteral, Bausch And Lomb Inc, and Novartis Pharms Corp, and is included in fifteen NDAs. There are thirty-four 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 and four patent family members in thirty-one countries.
There are eleven drug master file entries for brimonidine tartrate. Eight suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for brimonidine tartrate
| International Patents: | 204 |
| US Patents: | 34 |
| Tradenames: | 8 |
| Applicants: | 9 |
| NDAs: | 15 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 105 |
| Clinical Trials: | 40 |
| Patent Applications: | 1,442 |
| Drug Prices: | Drug price information for brimonidine tartrate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for brimonidine tartrate |
| DailyMed Link: | brimonidine tartrate at DailyMed |
Pharmacology for brimonidine tartrate
| Drug Class | alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for brimonidine tartrate
Synonyms for brimonidine tartrate
| (4,5-Bihydro-1H-imidazol-2-yl)quinoxalin-6-amine L-tartrate |
| (5-Bromo-quinoxalin-6-yl)-(4,5-dihydro-1h-imidazol-2-yl)-amine L-tartrate |
| 109826-56-4 |
| 1400635-36-0 |
| 359B465 |
| 4S9CL2DY2H |
| 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline l-tartrate |
| 5-bromo-6-(2-imidazolin-2-ylamino)quinoxaline tartrate |
| 5-bromo-N- |
| 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine L-Tartrate |
| 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine tartrate |
| 5-Bromo-N-(4,5-Dihydro-1H-Imidazol-2-yl)-6-Quinoxalinamine TaTRate |
| 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine (2R,3R)-2,3-dihydroxysuccinate |
| 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine; (2R,3R)-2,3-dihydroxybutanedioic acid |
| 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine; (2S,3S)-2,3-dihydroxybutanedioic acid |
| 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine(2R,3R)-2,3-dihydroxysuccinate |
| 59803-98-4 (Parent) |
| 59803-99-5 |
| 6-Quinoxalinamine, 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-, (R-(R*,R*))-2,3-dihydroxybutanedioate (1:1) |
| 6-Quinoxalinamine, 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-, (S-(R*,R*))-2,3-dihydroxybutanedioate (1:1) |
| 70359-46-5 |
| 79570-19-7 |
| A19740 |
| AB0021226 |
| AC-3599 |
| AC1L1GYC |
| AC1OCEPC |
| AC1Q59OR |
| ACT08633 |
| AGN 190342-LF |
| AGN 190342LF |
| AGN-190342-LF |
| Aiphagan |
| Aiphagan P |
| AK-68418 |
| AK142929 |
| AKOS015895446 |
| AKOS016845265 |
| AKOS022175702 |
| Alphagan |
| Alphagan (TN) |
| Alphagan Z |
| AN-12800 |
| API0007067 |
| API0007142 |
| AS-12798 |
| AS-18083 |
| AX8282531 |
| BC004062 |
| BC208828 |
| Brimonidine D-tartarate |
| Brimonidine D-tartrate |
| Brimonidine L-tartarate |
| Brimonidine L-Tartrate |
| brimonidine Purite |
| Brimonidine tartarate |
| brimonidine tartrate (1:1), (S-(R*,R*))-isomer |
| Brimonidine tartrate (JAN/USAN) |
| Brimonidine tartrate [USAN:JAN] |
| Brimonidine tartrate [USAN] |
| Brimonidine tartrateUK 14,304 tartrate |
| Brimonidinne tartrate |
| Brominide tartrate |
| C11H10BrN5.C4H6O6 |
| C15H16BrN5O6 |
| CCG-221278 |
| CHEMBL2062257 |
| CS-4496 |
| CTK3J3327 |
| D00ARM |
| D02076 |
| DR002734 |
| DTXSID20426066 |
| EBD23481 |
| FT-0082637 |
| HMS3652B06 |
| HY-B0659A |
| I06-0561 |
| KB-42499 |
| KS-00000K6V |
| KSC493G2P |
| L(+)-TARTARIC ACID; BRIMONIDINE |
| LS-177484 |
| LS40084 |
| MFCD07773072 |
| MolPort-003-845-306 |
| MolPort-016-638-379 |
| MolPort-023-220-671 |
| MolPort-035-395-833 |
| N-(5-bromoquinoxalin-6-yl)imidazolidin-2-imine;(2R,3R)-2,3-dihydroxybutanedioic acid |
| Novadur |
| PubChem15967 |
| Qoliana |
| RT-001413 |
| S-8158 |
| S4266 |
| SCHEMBL265607 |
| SCHEMBL34647 |
| SCHEMBL34649 |
| SNJ-2022 |
| ST24046243 |
| ST51052789 |
| TL8006987 |
| UK 14,304 (tartrate) |
| UK 14,304 tartrate |
| UK-14304-18 |
| UK-1430418 |
| UK14,304TARTRATE |
| UNII-4S9CL2DY2H |
| VA10431 |
| W0014 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | ➤ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | ➤ Sign Up | ➤ Sign Up |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | ➤ Sign Up | ➤ Sign Up |
| Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | ➤ Sign Up | ➤ Sign Up |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | ➤ Sign Up | ➤ Sign Up |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021770-001 | Aug 19, 2005 | ➤ Sign Up | ➤ Sign Up |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | ➤ 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
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Mexico | 2013004473 | ➤ Sign Up |
| Portugal | 2320911 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2004105703 | ➤ Sign Up |
| China | 101816793 | ➤ Sign Up |
| China | 1441679 | ➤ Sign Up |
| Cyprus | 1113391 | ➤ Sign Up |
| Russian Federation | 2519676 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for brimonidine tartrate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0683 | Netherlands | ➤ Sign Up | 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 |
| C0056 | France | ➤ Sign Up | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
| 14/041 | Ireland | ➤ Sign Up | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
| 1 5019-2014 | Slovakia | ➤ Sign Up | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221 |
| 1631293/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014 |
| 462 | 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 |
| 00683 | Netherlands | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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