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SIMBRINZA Drug Profile
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When do Simbrinza patents expire, and when can generic versions of Simbrinza launch?
Simbrinza is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug.
This drug has forty-one patent family members in twenty-five countries.
The generic ingredient in SIMBRINZA is brimonidine tartrate; brinzolamide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; brinzolamide profile page.
US ANDA Litigation and Generic Entry Outlook for Simbrinza
Simbrinza was eligible for patent challenges on December 31st, 1968.
Summary for SIMBRINZA
| International Patents: | 41 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 7 |
| Drug Prices: | Drug price information for SIMBRINZA |
| DailyMed Link: | SIMBRINZA at DailyMed |
Recent Clinical Trials for SIMBRINZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cornerstone Health Care, PA | Phase 4 |
| Allergan | Phase 4 |
| Alcon Research | Phase 4 |
Pharmacology for SIMBRINZA
| Drug Class | Carbonic Anhydrase Inhibitor alpha-Adrenergic Agonist |
| Mechanism of Action | Carbonic Anhydrase Inhibitors Adrenergic alpha-Agonists |
Synonyms for SIMBRINZA
| Brimonidine / brinzolamide |
| Brimonidine / brinzolamide tartrate |
| Brimonidine mixture with brinzolamide |
| Brimonidine mixture with brinzolamide tartrate |
| Brinzolamide / Brimonidine |
| S900006210 |
US Patents and Regulatory Information for SIMBRINZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SIMBRINZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251-001 | Apr 19, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SIMBRINZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2584858 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2010148190 | Start Trial |
| Mexico | 2011013107 | Start Trial |
| Argentina | 077126 | Start Trial |
| Taiwan | I489997 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SIMBRINZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1631293 | 2014C/042 | Belgium | Start Trial | PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221 |
| 1631293 | 92462 | Luxembourg | Start Trial | PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225 |
| 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 | 300683 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
