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Last Updated: September 25, 2022

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-seven patent family members in twelve countries.

The generic ingredient in GIAZO is balsalazide disodium. There are ten drug master file entries for this compound. Six 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 28th, 2007.

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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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS

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

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

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

International Patents for GIAZO

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

Country Patent Number Title Estimated Expiration
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) See Plans and Pricing
New Zealand 593132 BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF See Plans and Pricing
Brazil PI0717859 mÉtodos para aumentar a biodisponibilidade de um composto de 5-aminossalicilato, para aumentar a biodisponibilidade de 5-asa para o càlon de um indivÍduo, para retardar o trÂnsito de 5-asa no càlon de um indivÍduo, para diminuir o nÍvel sistÊmico de 5-asa em um indivÍduo, para diminuir a concentraÇço plasmÁtica mÁxima de um composto de 5-aminossalicilato em um indivÍduo, para retardar a tmax de um composto de 5-aminossalicilato em um indivÍduo, para diminuir o grau de absorÇço de um composto de 5-aminossalicilato em um indivÍduo, para aumentar a razço sistÊmica de nasa para 5-asa em um indivÍduo, para aumentar a conversço de 5-asa para nasa em um indivÍduo, para diminuir a taxa e grau de absorÇço de uma forma de dosagem oral de balsalazida, para usar balsalazida, e, para inibir o crescimento de uma espÉcie bacteriana em um indivÍduo humano See Plans and Pricing
Canada 2620091 PREPARATIONS DE BALSALAZIDE, LEUR PROCEDE D'OBTENTION ET LEURS UTILISATIONS (BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF) See Plans and Pricing
South Korea 20090118906 FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES See Plans and Pricing
Japan 2018145202 バルサラジドの製剤ならびにその製造および使用 (BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF) See Plans and Pricing
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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
McKinsey
Colorcon
Medtronic
Moodys

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