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Generated: June 27, 2017
What are the generic drug sources for brimonidine tartrate; timolol maleate and what is the scope of brimonidine tartrate; timolol maleate 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 eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 11 |
| Suppliers / Packagers: see list | 2 |
| Clinical Trials: see list | 496 |
| Drug Prices: | see low prices |
| DailyMed Link: | brimonidine tartrate; timolol maleate at DailyMed |
| Drug Class | beta-Adrenergic Blocker alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta-Antagonists Adrenergic alpha-Agonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 0.2%; 0.5% | SOLUTION; OPHTHALMIC |
| ► Subscribe | ► Subscribe | 0.2%; 0.5% | SOLUTION; OPHTHALMIC |
| ► Subscribe | ► Subscribe | 0.2%; 0.5% | SOLUTION; OPHTHALMIC |
| 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 | 9,474,751 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | 8,133,890 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | 7,030,149 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | 7,323,463 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Allergan | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | RX | Yes | Yes | 8,354,409 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| New Zealand | 528945 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1496912 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1516588 | ► Subscribe | |||||||||||||||||||||||||||
| Ecuador | SP034742 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20044450 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 462 | Luxembourg | ► Subscribe | PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225 | ||||||||||||||||||||||||||
| C0056 | France | ► Subscribe | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 | ||||||||||||||||||||||||||
| 00683 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 0683 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 14/041 | Ireland | ► Subscribe | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 | ||||||||||||||||||||||||||
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