GIAZO Drug Patent Profile

When do Giazo patents expire, and what generic alternatives are available?

Giazo is a drug marketed by Valeant Pharms Intl and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-five patent family members in twelve countries.

The generic ingredient in GIAZO is balsalazide disodium. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Giazo

A generic version of GIAZO was approved as balsalazide disodium by APOTEX INC on December 28^th, 2007.

Summary for GIAZO

International Patents:	45
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Patent Applications:	4,027
Drug Prices:	Drug price information for GIAZO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GIAZO
DailyMed Link:	GIAZO at DailyMed

See drug prices for GIAZO

Anatomical Therapeutic Chemical (ATC) Classes for GIAZO

A07EC	Aminosalicylic acid and similar agents
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for GIAZO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GIAZO	Tablets	balsalazide disodium	1.1 g	022205	1	2013-11-05

US Patents and Regulatory Information for GIAZO

GIAZO is protected by four US patents.

Patents protecting GIAZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No

Expired US Patents for GIAZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012

International Patents for GIAZO

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

Country	Patent Number	Title	Estimated Expiration
China	103948609	Balsalazide formulations and manufacture and use thereof
Australia	2011245455	Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males
New Zealand	603744	Balsalazide formulations and manufacture and use thereof
Brazil	9808140
European Patent Office	2096912	PRÉPARATIONS À BASE DE DÉRIVÉS D'ACIDE 2-HYDROXY-5-PHÉNYLAZOBENZOÏQUE ET LEURS APPLICATIONS (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES)
Brazil	112012027520	formulações e usos de derivados de ácido 2-hidroxi-5-fenilazobenzoico para o tratamento de indivíduos do sexo masculino