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Generated: September 20, 2017
What are the generic drug sources for brimonidine tartrate and what is the scope of brimonidine tartrate freedom to operate?
Brimonidine tartrate is the generic ingredient in seven branded drugs marketed by Galderma Labs Lp, Allergan, Akorn, Sandoz Inc, Bausch And Lomb, Teva Parenteral, Indoco Remedies, and Novartis Pharms Corp, and is included in fourteen NDAs. There are twenty-eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 28 |
| Applicants: | 8 |
| NDAs: | 14 |
| Drug Master File Entries: see list | 11 |
| Suppliers / Packagers: see list | 11 |
| Bulk Api Vendors: see list | 79 |
| Clinical Trials: see list | 213 |
| Patent Applications: see list | 1,276 |
| Therapeutic Class: | Ophthalmic Agents |
| Drug Prices: | see low prices |
| DailyMed Link: | brimonidine tartrate at DailyMed |
| Drug Class | alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 0.1% | SOLUTION; OPHTHALMIC |
| ► Subscribe | ► Subscribe | 0.2%; 0.5% | SOLUTION; OPHTHALMIC |
| ► Subscribe | ► Subscribe | 0.2%; 0.5% | SOLUTION; OPHTHALMIC |
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,838,563 | Compounds, formulations, and methods for ameliorating telangiectasias | ► Subscribe | |||||||||||||||||||||||||||
| 8,611,848 | Method and system for providing tiered access to communication network resources | ► Subscribe | |||||||||||||||||||||||||||
| 8,586,586 | Methods and compositions for treating or preventing erythema | ► Subscribe | |||||||||||||||||||||||||||
| 8,557,817 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | ► Subscribe | |||||||||||||||||||||||||||
| 9,258,687 | Method and system for providing tiered access to communication network resources | ► Subscribe | |||||||||||||||||||||||||||
| 8,275,349 | Method and system for providing tiered priority access to communication network resources | ► Subscribe | |||||||||||||||||||||||||||
| 8,993,571 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | ► Subscribe | |||||||||||||||||||||||||||
| 8,892,066 | Method and system for providing tiered priority access to communication network resources | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2547336 | ► Subscribe | |||||||||||||||||||||||||||
| China | 103298451 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 552325 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2011231543 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2567401 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2424644 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 0301405 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2153819 | ► Subscribe | |||||||||||||||||||||||||||
| Cyprus | 1116690 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1761266 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0056 | France | ► Subscribe | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 | ||||||||||||||||||||||||||
| 2014000080 | Germany | ► Subscribe | PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 0140022 00150 | Estonia | ► Subscribe | PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014 | ||||||||||||||||||||||||||
| 90049-2 | Sweden | ► Subscribe | PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221 | ||||||||||||||||||||||||||
| 1 5019-2014 | Slovakia | ► Subscribe | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221 | ||||||||||||||||||||||||||
| 14/041 | Ireland | ► Subscribe | PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221 | ||||||||||||||||||||||||||
| 2014 00031 | Denmark | ► Subscribe | PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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