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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

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, Hikma Pharms, 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. Six 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

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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 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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Par Pharm Inc BALSALAZIDE DISODIUM balsalazide disodium TABLET;ORAL 206336-001 Sep 8, 2015 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma Pharms BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077806-001 Dec 28, 2007 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Express Scripts
Moodys
Johnson and Johnson
AstraZeneca

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