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Last Updated: January 25, 2020

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BALSALAZIDE DISODIUM Drug Profile

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When do Balsalazide Disodium patents expire, and what generic alternatives are available?

Balsalazide Disodium is a drug marketed by Apotex Inc, Hikma, Mylan, and Par Pharm Inc. and is included in four NDAs.

The generic ingredient in BALSALAZIDE DISODIUM 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 Balsalazide Disodium

A generic version of BALSALAZIDE DISODIUM was approved as balsalazide disodium by APOTEX INC on January 25th, 2020.

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Drug patent expirations by year for BALSALAZIDE DISODIUM
Drug Prices for BALSALAZIDE DISODIUM

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Recent Clinical Trials for BALSALAZIDE DISODIUM

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SponsorPhase
Valeant Pharmaceuticals International, Inc.Phase 3
Roxane LaboratoriesN/A
Mylan PharmaceuticalsPhase 1

See all BALSALAZIDE DISODIUM clinical trials

Recent Litigation for BALSALAZIDE DISODIUM

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 BALSALAZIDE DISODIUM litigation

Pharmacology for BALSALAZIDE DISODIUM
Drug ClassAminosalicylate
Paragraph IV (Patent) Challenges for BALSALAZIDE DISODIUM
Tradename Dosage Ingredient NDA Submissiondate
GIAZO TABLET;ORAL balsalazide disodium 022205 2013-11-05

US Patents and Regulatory Information for BALSALAZIDE DISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883-001 Dec 28, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc BALSALAZIDE DISODIUM balsalazide disodium TABLET;ORAL 206336-001 Sep 8, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077806-001 Dec 28, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 DISCN No No   Start Trial   Start Trial   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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