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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-six 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.

US ANDA Litigation and Generic Entry Outlook for Combigan

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 19, 2022. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $308mm indicating the motivation for generic entry (peak sales were $398mm in 2016).

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (brimonidine tartrate; timolol maleate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for COMBIGAN

International Patents:	26
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
Drug Sales Revenues:	Drug sales revenues for COMBIGAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMBIGAN
What excipients (inactive ingredients) are in COMBIGAN?	COMBIGAN excipients list
DailyMed Link:	COMBIGAN at DailyMed

See drug prices for COMBIGAN

See drug sales revenues for COMBIGAN

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.

Recent Clinical Trials for COMBIGAN

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

Sponsor	Phase
EMS	Phase 3
McMaster University	N/A
Carmel Medical Center	Phase 2

See all COMBIGAN clinical trials

Pharmacology for COMBIGAN

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

Paragraph IV (Patent) Challenges for COMBIGAN

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

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

International Patents for COMBIGAN

Country	Patent Number	Estimated Expiration
Mexico	368377
South Korea	20040100844
Hong Kong	1067549
European Patent Office	1496912
Brazil	0302584
Norway	326579

Supplementary Protection Certificates for COMBIGAN

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
1631293	2014C/042	Belgium		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	300683	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	92462	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