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Last Updated: August 11, 2022

COLAZAL Drug Patent Profile


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

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

This drug has thirty-seven patent family members in twelve countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Colazal

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

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Drug patent expirations by year for COLAZAL
Drug Prices for COLAZAL

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Recent Clinical Trials for COLAZAL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Roxane LaboratoriesN/A
Mylan PharmaceuticalsPhase 1

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Paragraph IV (Patent) Challenges for COLAZAL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COLAZAL Capsules balsalazide disodium 750 mg 020610 1 2022-05-26

US Patents and Regulatory Information for COLAZAL

COLAZAL is protected by two US patents.

Patents protecting COLAZAL

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Patent Number: See Plans and Pricing
Patent Expiration: 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
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 COLAZAL

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

Country Patent Number Title Estimated Expiration
United Kingdom 2080796 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008063211 See Plans and Pricing
Japan 6067203 See Plans and Pricing
China 101610670 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives See Plans and Pricing
South Korea 20140098863 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
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Baxter
Johnson and Johnson
Medtronic
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.