GIAZO Drug Patent Profile

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

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. Nine 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.

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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

Drug patent expirations by year for GIAZO

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

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS

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Glossary

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

Expired US Patents for GIAZO

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for GIAZO

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011137103		⤷ Sign Up
Australia	2011245455	Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males	⤷ Sign Up
China	102670626	Balsalazide formulations and manufacture and use thereof	⤷ Sign Up
Mexico	2009004826	FORMULACIONES Y USOS DE DERIVADOS DE ACIDO 2-HIDROXI-5-FENILAZOBEN ZOICO. (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES.)	⤷ Sign Up
Norway	994431		⤷ Sign Up
Brazil	112012027520	formulações e usos de derivados de ácido 2-hidroxi-5-fenilazobenzoico para o tratamento de indivíduos do sexo masculino	⤷ Sign Up
Canada	2797560	FORMULATIONS ET UTILISATIONS DE DERIVES D'ACIDE 2-HYDROXY-5-PHENYLAZOBENZOIQUE POUR LE TRAITEMENT DE SUJETS MALES (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES FOR THE TREATMENT OF MALES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for GIAZO

Paragraph IV (Patent) Challenges for GIAZO

Patents protecting GIAZO

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