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Last Updated: March 29, 2024

BALSALAZIDE DISODIUM - Generic Drug Details


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What are the generic drug sources for balsalazide disodium and what is the scope of patent protection?

Balsalazide disodium is the generic ingredient in three branded drugs marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus, Valeant Pharms Intl, and Strides Pharma, and is included in seven NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Balsalazide disodium has forty-five patent family members in twelve countries.

There are ten drug master file entries for balsalazide disodium. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

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

Generic filers with tentative approvals for BALSALAZIDE DISODIUM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1.1GMTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1.1GTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

Expired US Patents for BALSALAZIDE DISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BALSALAZIDE DISODIUM

Country Patent Number Title Estimated Expiration
China 101247812 Balsalazide formulations and manufacture and use thereof ⤷  Try a Trial
Japan 2013032395 FORMULATION AND USE OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVE ⤷  Try a Trial
Denmark 2096912 ⤷  Try a Trial
Japan 2013525440 ⤷  Try a Trial
Canada 2816276 PREPARATIONS DE BALSALAZIDE, LEUR PROCEDE D'OBTENTION ET LEURS UTILISATIONS (BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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