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Last Updated: December 12, 2019

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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
Drug patent expirations by year for SIMBRINZA
Drug Prices for SIMBRINZA

See drug prices for SIMBRINZA

Recent Clinical Trials for SIMBRINZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cornerstone Health Care, PAPhase 4
AllerganPhase 4
Alcon ResearchPhase 4

See all SIMBRINZA clinical trials

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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Baxter
Moodys
Boehringer Ingelheim
AstraZeneca

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