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COMBIGAN Drug Profile

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Which patents cover Combigan, and what generic alternatives are available?

Combigan is a drug marketed by Allergan and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in nineteen countries.

The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. 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; timolol maleate profile page.

Summary for COMBIGAN

International Patents:	25
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	19
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for COMBIGAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMBIGAN
DailyMed Link:	COMBIGAN at DailyMed

Generic Entry Opportunity Date for COMBIGAN

NDA:

021398

Dosage:

SOLUTION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for COMBIGAN

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

Synonyms for COMBIGAN

2-Propanol, 1-((1,1-dimethylethyl)amino)-3-((4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl)oxy)-, (2S)-, mixt. with 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine

952743-07-6

Brimonidine / timolol

Brimonidine mixture with timolol

Brimonidine tartrate / timolol maleate

Brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination

Brimonidine tartrate and timolol maleate

Brimonidine Tartrate, Timolol Maleate Drug Combination

SCHEMBL5873369

US Patents and Regulatory Information for COMBIGAN

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

Paragraph IV (Patent) Challenges for COMBIGAN

Drugname	Dosage	Strength	RLD	Date
	Ophthalmic Solution	0.2%/0.5%

International Patents for COMBIGAN

Country	Document Number	Estimated Expiration
South Korea	20040100844
Hong Kong	1067549
Slovenia	1496912
Australia	2003228480

Supplementary Protection Certificates for COMBIGAN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00683	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
C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
14/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225