DrugPatentWatch Database Preview

Brimonidine tartrate; timolol maleate - Generic Drug Details

« Back to Dashboard

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

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

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
		0.2%; 0.5%	SOLUTION; OPHTHALMIC
		0.2%; 0.5%	SOLUTION; OPHTHALMIC
		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

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

International Patents for brimonidine tartrate; timolol maleate

Country	Patent Number	Estimated Expiration
Norway	326579
Denmark	1496912
Norway	20044450

Supplementary Protection Certificates for brimonidine tartrate; timolol maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	C300683	Netherlands		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	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225