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Brimonidine tartrate - Generic Drug Details
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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, 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 twenty-two patent family members in thirty-two 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: | 222 |
US Patents: | 35 |
Tradenames: | 8 |
Applicants: | 10 |
NDAs: | 16 |
Drug Master File Entries: | 11 |
Suppliers / Packagers: | 8 |
Bulk Api Vendors: | 123 |
Clinical Trials: | 47 |
Patent Applications: | 1,658 |
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 |
Uptown Eye Specialists | N/A |
Wendy Lee | Phase 4 |
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
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MIRVASO | GEL;TOPICAL | brimonidine tartrate | 204708 | 2014-12-15 |
ALPHAGAN P | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate | 021770 | 2006-12-20 |
ALPHAGAN P | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate | 021262 | 2006-11-03 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Parenteral | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 076372-001 | Sep 10, 2004 | DISCN | No | No | Start Trial | Start Trial | 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 | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | 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 P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | 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 | 2016111112 | Start Trial |
Cyprus | 1113391 | Start Trial |
Poland | 1631293 | Start Trial |
European Patent Office | 2515917 | Start Trial |
Poland | 2444068 | Start Trial |
Hong Kong | 1084591 | Start Trial |
Japan | 2014520068 | 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 | C 2014 030 | Romania | Start Trial | PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221 |
1631293 | 132014902284452 | Italy | Start Trial | PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221 |
1631293 | 1490049-2 | Sweden | Start Trial | PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221 |
1631293 | C20140022 00150 | Estonia | Start Trial | PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014 |
1631293 | CR 2014 00031 | Denmark | Start Trial | PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221 |
1631293 | 300683 | 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 |
1631293 | 14C0056 | France | Start 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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