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Last Updated: February 23, 2024

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. 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 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
China 101247812 Balsalazide formulations and manufacture and use thereof ⤷  Try a Trial
New Zealand 603744 Balsalazide formulations and manufacture and use thereof ⤷  Try a Trial
European Patent Office 1003524 ⤷  Try a Trial
Israel 189104 תכשיר רוקחי המכיל בלסלאזיד או סודיום בלסלאזיד לשימוש בטיפול במחלות דרכי העיכול. (Pharmaceutical preparation comprising balsalazide or balsalazide disodium for use in treating gastrointestinal disease) ⤷  Try a Trial
Canada 3004028 PREPARATIONS A BASE DE DERIVES D'ACIDE 2-HYDROXY-5-PHENYLAZOBENZOIQUE ET LEURS APPLICATIONS (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES) ⤷  Try a Trial
>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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