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Last Updated: November 2, 2024

BALSALAZIDE DISODIUM Drug Patent Profile


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Which patents cover Balsalazide Disodium, and when can generic versions of Balsalazide Disodium launch?

Balsalazide Disodium is a drug marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus Lifesciences, and Strides Pharma. and is included in five NDAs.

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

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

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

SponsorPhase
Bausch Health Americas, Inc.Phase 3
Valeant Pharmaceuticals International, Inc.Phase 3
Roxane LaboratoriesN/A

See all BALSALAZIDE DISODIUM clinical trials

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 217592-001 Jun 8, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dash Pharms Natco BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077806-001 Dec 28, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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