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Generated: July 21, 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-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 29 |
| 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 | 211 |
| 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 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | RX | Yes | Yes | 6,316,441 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | 8,231,885 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | AT | RX | Yes | Yes | 6,673,337*PED | ► Subscribe | Y | ► 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 | ||||||||||||||||
Akorn | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 076439-001 | Mar 14, 2006 | AT | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | 5,736,165*PED | ► Subscribe | ||||||||||||||||||||||
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | 6,194,415*PED | ► Subscribe | ||||||||||||||||||||||
Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | 6,194,415*PED | ► Subscribe | ||||||||||||||||||||||
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | 6,248,741*PED | ► Subscribe | ||||||||||||||||||||||
Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | 6,465,464*PED | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,611,848 | Method and system for providing tiered access to communication network resources | ► Subscribe | |||||||||||||||||||||||||||
| 8,892,066 | Method and system for providing tiered priority access to communication network resources | ► Subscribe | |||||||||||||||||||||||||||
| 7,838,563 | Compounds, formulations, and methods for ameliorating telangiectasias | ► Subscribe | |||||||||||||||||||||||||||
| 8,993,571 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | ► Subscribe | |||||||||||||||||||||||||||
| 8,557,817 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Africa | 200209877 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2519676 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2571277 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20056104 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2001273268 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||||||||||||||
| 1 5019-2014 | Slovakia | ► Subscribe | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 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 | ||||||||||||||||||||||||||
| C0056 | France | ► Subscribe | PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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