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Brimonidine tartrate - Generic Drug Details
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This ingredient has one hundred and forty-two patent family members in thirty-one countries.
There are eleven drug master file entries for brimonidine tartrate. Eleven suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for Generic Name: brimonidine tartrate
| Tradenames: | 7 |
| Patents: | 25 |
| Applicants: | 9 |
| NDAs: | 14 |
| Drug Master File Entries: see list | 11 |
| Suppliers / Packaging: see list | 11 |
| Therapeutic Class: | Ophthalmic Agents |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: brimonidine tartrate
| Drug Class | alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
Tentative approvals for BRIMONIDINE TARTRATE
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | SOLUTION; OPHTHALMIC | 0.1% |
| <disabled> | <disabled> | SOLUTION; OPHTHALMIC | 0.2%; 0.5% |
| <disabled> | <disabled> | SOLUTION; OPHTHALMIC | 0.2%; 0.5% |
Clinical Trials for: brimonidine tartrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | 8,513,249 | Mar 25, 2031 | Y | |||||||||||||||||||
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | RX | Yes | 6,641,834*PED | Jan 28, 2022 | Y | |||||||||||||||||||
Akorn | BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 076439-001 | Mar 14, 2006 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: brimonidine tartrate
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | ALPHAGAN | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 020613-001 | Sep 6, 1996 | 6,194,415*PED | <disabled> | ||||||||||||||||||||||
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | 6,248,741*PED | <disabled> | ||||||||||||||||||||||
Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | 5,424,078*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: brimonidine tartrate
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,892,066 | Method and system for providing tiered priority access to communication network resources | <disabled in preview> | |||||||||||||||||||||||||||
| 8,557,817 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | <disabled in preview> | |||||||||||||||||||||||||||
| 8,586,586 | Methods and compositions for treating or preventing erythema | <disabled in preview> | |||||||||||||||||||||||||||
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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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International Patent Family for Ingredient: brimonidine tartrate
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2416169 | <disabled in preview> | |||||||||||||||||||||||||||
| Slovenia | 2388007 | <disabled in preview> | |||||||||||||||||||||||||||
| Brazil | PI0514723 | <disabled in preview> | |||||||||||||||||||||||||||
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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 Certificates for Tradename: BRIMONIDINE TARTRATE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 5019-2014 | Slovakia | <disabled> | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221 | ||||||||||||||||||||||||||
| 462 | Luxembourg | <disabled> | PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225 | ||||||||||||||||||||||||||
| 2014 00031 | Denmark | <disabled> | PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221 | ||||||||||||||||||||||||||
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