BRIMONIDINE TARTRATE; BRINZOLAMIDE - Generic Drug Details

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What are the generic drug sources for brimonidine tartrate; brinzolamide and what is the scope of patent protection?

Brimonidine tartrate; brinzolamide is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; brinzolamide has forty-one patent family members in twenty-five countries.

There are eleven drug master file entries for brimonidine tartrate; brinzolamide. One supplier is listed for this compound.

Summary for BRIMONIDINE TARTRATE; BRINZOLAMIDE

International Patents:	41
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	11
Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	BRIMONIDINE TARTRATE; BRINZOLAMIDE at DailyMed

Recent Clinical Trials for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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

Sponsor	Phase
Alcon Research	Phase 2
Alcon Research	N/A
Hermann Eye Center	N/A

See all BRIMONIDINE TARTRATE; BRINZOLAMIDE clinical trials

Pharmacology for BRIMONIDINE TARTRATE; BRINZOLAMIDE

Drug Class	Carbonic Anhydrase Inhibitor alpha-Adrenergic Agonist
Mechanism of Action	Carbonic Anhydrase Inhibitors Adrenergic alpha-Agonists

US Patents and Regulatory Information for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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Glossary

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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				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
>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 BRIMONIDINE TARTRATE; BRINZOLAMIDE

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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 BRIMONIDINE TARTRATE; BRINZOLAMIDE

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Country	Patent Number	Estimated Expiration
Cyprus	1117835	Start Trial
Denmark	2722035	Start Trial
Hong Kong	1163521	Start Trial
Croatia	P20160953	Start Trial
Taiwan	201100103	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2014/041	Ireland	Start Trial	PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	14C0056	France	Start Trial	PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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