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Brimonidine tartrate; timolol maleate - Generic Drug Details
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What are the generic drug sources for brimonidine tartrate; timolol maleate and what is the scope of freedom to operate?
Brimonidine tartrate; timolol maleate
is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Brimonidine tartrate; timolol maleate has twenty-six patent family members in nineteen countries.
There are eleven drug master file entries for brimonidine tartrate; timolol maleate. One supplier is listed for this compound. There are three tentative approvals for this compound.
Summary for brimonidine tartrate; timolol maleate
International Patents: | 26 |
US Patents: | 11 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 11 |
Suppliers / Packagers: | 1 |
Clinical Trials: | 6 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for brimonidine tartrate; timolol maleate |
DailyMed Link: | brimonidine tartrate; timolol maleate at DailyMed |
Recent Clinical Trials for brimonidine tartrate; timolol maleate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Allergan | Phase 3 |
Allergan | N/A |
Allergan | Phase 4 |
See all brimonidine tartrate; timolol maleate clinical trials
Generic filers with tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 0.2%; 0.5% | SOLUTION; OPHTHALMIC |
Start Trial | Start Trial | 0.2%; 0.5% | 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; timolol maleate
Drug Class | alpha-Adrenergic Agonist beta-Adrenergic Blocker |
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
COMBIGAN | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate; timolol maleate | 021398 | 2008-11-21 |
US Patents and Regulatory Information for brimonidine tartrate; timolol maleate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | 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 | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for brimonidine tartrate; timolol maleate
Country | Patent Number | Estimated Expiration |
---|---|---|
Norway | 326579 | Start Trial |
Denmark | 1496912 | Start Trial |
Norway | 20044450 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for brimonidine tartrate; timolol maleate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1631293 | 2014/041 | Ireland | Start Trial | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 |
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 |
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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