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Brimonidine tartrate - Generic Drug Details
What are the generic drug sources for brimonidine tartrate and what is the scope of 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, Somerset Theraps Llc, Teva Parenteral, Bausch And Lomb Inc, and Novartis, and is included in sixteen NDAs. There are thirty-five 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 seventeen 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 five tentative approvals for this compound.
Summary for brimonidine tartrate
| International Patents: | 217 |
| US Patents: | 35 |
| Tradenames: | 8 |
| Applicants: | 10 |
| NDAs: | 16 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 118 |
| Clinical Trials: | 45 |
| Patent Applications: | 1,610 |
| 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 |
| Wendy Lee | Phase 4 |
| Denver Health and Hospital Authority | Phase 2 |
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 |
| Start Trial | Start Trial | 0.15% | SOLUTION/DROPS;OPHTHALMIC |
| Start Trial | Start Trial | 0.1% | SOLUTION; OPHTHALMIC |
| Start Trial | Start Trial | 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 |
| 1400635-36-0 |
| 2,3-Dihydroxybutanedioic acid--5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine (1/1) |
| 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) quinoxalin-6-amine 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 |
| 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 |
| A19740 |
| AB0021226 |
| AC-3599 |
| ACT08633 |
| AGN 190342-LF |
| AGN 190342LF |
| AGN-190342-LF |
| AGN-190342LF |
| AGN190342 tartrate |
| Aiphagan |
| Aiphagan P |
| AK-68418 |
| AKOS015895446 |
| AKOS016845265 |
| Alphagan |
| Alphagan (TN) |
| Alphagan Z |
| Alphagan-P |
| API0007067 |
| API0007142 |
| AS-12798 |
| AS-18083 |
| AX8282531 |
| BC004062 |
| BCP28473 |
| Brimonidine (tartrate) |
| Brimonidine (UK-14304 ) |
| 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 |
| brimonidine-tartrate |
| Brimonidinne tartrate |
| Brominide tartrate |
| C11H10BrN5.C4H6O6 |
| C15H16BrN5O6 |
| CCG-221278 |
| CHEMBL2062257 |
| CS-4496 |
| CTK3J3327 |
| D02076 |
| DTXSID20426066 |
| DTXSID70911371 |
| EBD23481 |
| FT-0082637 |
| HMS3413O18 |
| HMS3652B06 |
| HMS3677O18 |
| HMS3715P18 |
| HY-B0659A |
| KS-00000K6V |
| KSC493G2P |
| LS-177484 |
| LS40084 |
| N-(5-bromoquinoxalin-6-yl)imidazolidin-2-imine;(2R,3R)-2,3-dihydroxybutanedioic acid |
| Novadur |
| PubChem15967 |
| Q27122452 |
| Qoliana |
| RT-001413 |
| S-8158 |
| S4266 |
| SCHEMBL265607 |
| SCHEMBL34647 |
| SCHEMBL34649 |
| SNJ-2022 |
| ST24046243 |
| SW219492-1 |
| UK 14,304 (tartrate) |
| UK 14,304 tartrate |
| UK-14304-18 |
| UK-1430418 |
| UK14304 tartrate |
| UNII-4S9CL2DY2H |
| VA10431 |
| W0014 |
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ALPHAGAN P | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate | 021770 | 2006-12-20 |
| ALPHAGAN P | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate | 021262 | 2006-11-03 |
| MIRVASO | GEL;TOPICAL | brimonidine tartrate | 204708 | |
| ALPHAGAN | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate | 020613 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 |
|---|---|---|---|---|---|---|---|
| Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | Start Trial | Start Trial |
| Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | Start Trial | Start Trial |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for brimonidine tartrate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2012145616 | Start Trial |
| China | 106038476 | Start Trial |
| European Patent Office | 1365811 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for brimonidine tartrate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | 1490049-2 | Sweden | Start Trial | PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221 |
| 1631293 | C01631293/01 | Switzerland | Start Trial | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014 |
| 1631293 | C300683 | Netherlands | Start 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 |
| >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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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