COMBIGAN Drug Patent Profile

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

Combigan is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Combigan

A generic version of COMBIGAN was approved as brimonidine tartrate; timolol maleate by SANDOZ on April 4^th, 2022.

Summary for COMBIGAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	21
Patent Applications:	56
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

Recent Clinical Trials for COMBIGAN

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

Sponsor	Phase
Salus University	Phase 4
EMS	Phase 3
McMaster University	N/A

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

Anatomical Therapeutic Chemical (ATC) Classes for COMBIGAN

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01ED	Beta blocking agents
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for COMBIGAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIGAN	Ophthalmic Solution	brimonidine tartrate; timolol maleate	0.2%/0.5%	021398	1	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
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	AB	RX	Yes	Yes

Expired US Patents for COMBIGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007

International Patents for COMBIGAN

See the table below for patents covering COMBIGAN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1496912	ASSOCIATION DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION OPHTALMOLOGIQUE TOPIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE)
Portugal	1496912
Brazil	0302584	Combinação de brimonidina e timolol para uso oftálmico tópico

Supplementary Protection Certificates for COMBIGAN

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