ALPHAGAN Drug Patent Profile

When do Alphagan patents expire, and when can generic versions of Alphagan launch?

Alphagan is a drug marketed by Allergan and Abbvie and is included in four NDAs. There is one patent protecting this drug.

The generic ingredient in ALPHAGAN is brimonidine tartrate. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alphagan

A generic version of ALPHAGAN was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28^th, 2003.

Summary for ALPHAGAN

US Patents:	0
Applicants:	2
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	25
Patent Applications:	406
Drug Prices:	Drug price information for ALPHAGAN
Drug Sales Revenues:	Drug sales revenues for ALPHAGAN
DailyMed Link:	ALPHAGAN at DailyMed

See drug prices for ALPHAGAN

Recent Clinical Trials for ALPHAGAN

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

Sponsor	Phase
University of Louisville	Phase 4
Wake Forest University Health Sciences	Phase 4
Uptown Eye Specialists	N/A

See all ALPHAGAN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ALPHAGAN

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

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

US Patents and Regulatory Information for ALPHAGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996		DISCN	Yes	No
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	AT	RX	Yes	Yes
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020490-001	Mar 13, 1997		DISCN	No	No
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	AB	RX	Yes	Yes

Expired US Patents for ALPHAGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996

International Patents for ALPHAGAN

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1146877	(2-IMIDAZOLINE-2-YLAMINO) QUINOXALINES DESTINEES AU TRAITEMENT DE LESIONS NERVEUSES ((2-IMIDAZOLIN-2-YLAMINO) QUINOXALINES FOR THE TREATMENT OF NEURAL INJURY)
Germany	69636012
Spain	2333339
Denmark	0835110

Supplementary Protection Certificates for ALPHAGAN

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	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	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/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