Brimonidine tartrate; timolol maleate - Generic Drug Details

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What are the generic drug sources for brimonidine tartrate; timolol maleate and what is the scope of freedom to operate?

Brimonidine tartrate; timolol maleate is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; timolol maleate has twenty-six patent family members in nineteen countries.

There are eleven drug master file entries for brimonidine tartrate; timolol maleate. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for brimonidine tartrate; timolol maleate

International Patents:	26
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	11
Suppliers / Packagers:	1
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brimonidine tartrate; timolol maleate
DailyMed Link:	brimonidine tartrate; timolol maleate at DailyMed

Recent Clinical Trials for brimonidine tartrate; timolol maleate

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Sponsor	Phase
Allergan	Phase 3
Allergan	N/A
Allergan	Phase 4

See all brimonidine tartrate; timolol maleate clinical trials

Generic filers with tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	0.2%; 0.5%	SOLUTION; OPHTHALMIC
Start Trial	Start Trial	0.2%; 0.5%	SOLUTION; OPHTHALMIC
Start Trial	Start Trial	0.2%; 0.5%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for brimonidine tartrate; timolol maleate

Drug Class	alpha-Adrenergic Agonist beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Antagonists

Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
COMBIGAN	SOLUTION/DROPS;OPHTHALMIC	brimonidine tartrate; timolol maleate	021398	2008-11-21

US Patents and Regulatory Information for brimonidine tartrate; timolol maleate

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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
Allergan	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Allergan	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Allergan	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007		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

International Patents for brimonidine tartrate; timolol maleate

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Country	Patent Number	Estimated Expiration
Hong Kong	1067549	Start Trial
European Patent Office	1496912	Start Trial
South Korea	100723189	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for brimonidine tartrate; timolol maleate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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