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Last Updated: March 29, 2024

BALSALAZIDE DISODIUM Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Balsalazide Disodium

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

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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
Bausch Health Americas, Inc.Phase 3
Roxane LaboratoriesN/A

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Pharmacology for BALSALAZIDE DISODIUM
Drug ClassAminosalicylate
Paragraph IV (Patent) Challenges for BALSALAZIDE DISODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COLAZAL Capsules balsalazide disodium 750 mg 020610 1 2022-05-26
GIAZO Tablets balsalazide disodium 1.1 g 022205 1 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 217592-001 Jun 8, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dash Pharms Natco BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 DISCN No 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

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