Last Updated: June 26, 2026

BALSALAZIDE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Balsalazide

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

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Summary for BALSALAZIDE
US Patents:0
Applicants:6
NDAs:6
Drug Prices: Drug price information for BALSALAZIDE
DailyMed Link:BALSALAZIDE at DailyMed

US Patents and Regulatory Information for BALSALAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883-001 Dec 28, 2007 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novitium Pharma BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Carnegie BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 219422-001 Apr 3, 2025 AB RX 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
>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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