ALPHAGAN P Drug Patent Profile

Which patents cover Alphagan P, and when can generic versions of Alphagan P launch?

Alphagan P is a drug marketed by Abbvie and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has thirty-eight patent family members in nineteen countries.

The generic ingredient in ALPHAGAN P 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 P

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

Summary for ALPHAGAN P

International Patents:	38
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	25
Drug Prices:	Drug price information for ALPHAGAN P
Drug Sales Revenues:	Drug sales revenues for ALPHAGAN P
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALPHAGAN P
What excipients (inactive ingredients) are in ALPHAGAN P?	ALPHAGAN P excipients list
DailyMed Link:	ALPHAGAN P at DailyMed

See drug prices for ALPHAGAN P

See drug sales revenues for ALPHAGAN P

Recent Clinical Trials for ALPHAGAN P

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 P clinical trials

Pharmacology for ALPHAGAN P

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Paragraph IV (Patent) Challenges for ALPHAGAN P

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.1%	021770	1	2006-12-20
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.15%	021262	1	2006-11-03

US Patents and Regulatory Information for ALPHAGAN P

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

Expired US Patents for ALPHAGAN P

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001

International Patents for ALPHAGAN P

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

Country	Patent Number	Title	Estimated Expiration
Japan	2002534387
Brazil	PI0514723
New Zealand	231458	AQUEOUS OHPTHALMIC SOLUTION CONTAINING A MINOR PROPORTION OF CHLORINE DIOXIDE AS A PRESERVATIVE

Supplementary Protection Certificates for ALPHAGAN P

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221