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Last Updated: January 20, 2020

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COLAZAL Drug Profile

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Which patents cover Colazal, and what generic alternatives are available?

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

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.

US ANDA Litigation and Generic Entry Outlook for Colazal

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A generic version of COLAZAL was approved as balsalazide disodium by APOTEX INC on January 20th, 2020.

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

Roxane LaboratoriesN/A
Mylan PharmaceuticalsPhase 1

See all COLAZAL clinical trials

Recent Litigation for COLAZAL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Salix Pharmaceuticals, Inc. v. Apotex, Inc.2015-09-30
Salix Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc.2014-07-17

See all COLAZAL litigation

US Patents and Regulatory Information for COLAZAL

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   Start Trial   Start Trial Y   Start Trial
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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