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Brimonidine tartrate - Generic Drug Details
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 eight branded drugs marketed by Galderma Labs Lp, Allergan, Akorn, Bausch And Lomb, Indoco Remedies, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Bausch And Lomb Inc, and Novartis Pharms Corp, and is included in sixteen NDAs. There are thirty-six 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 twelve patent family members in thirty-one countries.
There are eleven drug master file entries for brimonidine tartrate. Nine suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for brimonidine tartrate
| International Patents: | 212 |
| US Patents: | 36 |
| Tradenames: | 8 |
| Applicants: | 10 |
| NDAs: | 16 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 116 |
| Clinical Trials: | 45 |
| Patent Applications: | 1,579 |
| Drug Prices: | Drug price trends for brimonidine tartrate |
| Drug Sales Revenues: | Drug sales revenues for brimonidine tartrate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for brimonidine tartrate |
| 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 |
| Denver Health and Hospital Authority | Phase 2 |
| Wendy Lee | Phase 4 |
Recent Litigation for brimonidine tartrate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Galderma Laboratories, L.P. v. Perrigo UK FINCO L.P. | 2016-08-19 |
| Galderma Laboratories LP v. Actavis Laboratories UT Inc. | 2015-03-12 |
| AIP Acquisition LLC v. Level 3 Communications LLC | 2012-05-17 |
Generic filers with tentative approvals for BRIMONIDINE TARTRATE
| Applicant | Application No. | Strength | Dosage Form |
| See Pricing | See Pricing | 0.1% | SOLUTION; OPHTHALMIC |
| See Pricing | See Pricing | 0.2%; 0.5% | SOLUTION; OPHTHALMIC |
| See Pricing | See Pricing | 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
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 |
| 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 |
| AKOS015895446 |
| AKOS016845265 |
| AKOS022175702 |
| Alphagan |
| Alphagan (TN) |
| Alphagan Z |
| Alphagan-P |
| AN-12800 |
| API0007067 |
| API0007142 |
| AS-12798 |
| AS-18083 |
| AX8282531 |
| BC004062 |
| BC208828 |
| BCP28473 |
| Brimonidine (tartrate) |
| 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 |
| D02076 |
| DTXSID20426066 |
| EBD23481 |
| FT-0082637 |
| HMS3652B06 |
| HMS3715P18 |
| HY-B0659A |
| I06-0561 |
| KB-42499 |
| KS-00000K6V |
| KSC493G2P |
| LS-177484 |
| LS40084 |
| 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 |
| SW219492-1 |
| TL8006987 |
| UK 14,304 (tartrate) |
| UK 14,304 tartrate |
| UK-14304-18 |
| UK-1430418 |
| 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 | See Pricing | See Pricing | See Pricing | ||||
| Novartis Pharms Corp | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Sandoz Inc | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 078075-001 | Jan 30, 2008 | AT | RX | No | No | See Pricing | See Pricing | See Pricing | |||
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021770-001 | Aug 19, 2005 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Teva Parenteral | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 076372-001 | Sep 10, 2004 | DISCN | No | No | See Pricing | See Pricing | See Pricing | ||||
| Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020490-001 | Mar 13, 1997 | DISCN | No | No | See Pricing | See Pricing | See Pricing | ||||
| >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 | See Pricing | See Pricing |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | See Pricing | See Pricing |
| Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | See Pricing | See Pricing |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | See Pricing | See Pricing |
| Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | See Pricing | See Pricing |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | See Pricing | See Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for brimonidine tartrate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1115683 | See Pricing |
| South Africa | 200207413 | See Pricing |
| San Marino | T201400156 | See Pricing |
| New Zealand | 610121 | See Pricing |
| China | 106038476 | See Pricing |
| Slovenia | 1631293 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for brimonidine tartrate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | 14C0056 | France | See Pricing | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
| 1631293 | 2014C/042 | Belgium | See Pricing | 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 | 2014/041 | Ireland | See Pricing | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
| 1631293 | C300683 | Netherlands | See Pricing | 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 | 122014000080 | Germany | See Pricing | PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
| 1631293 | 191 5019-2014 | Slovakia | See Pricing | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.