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Last Updated: November 2, 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 Lifesciences, 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. Nine 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
Valeant Pharmaceuticals International, Inc.Phase 3
Bausch Health Americas, 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
⤷  Sign Up⤷  Sign Up1.1GMTABLET;ORAL
⤷  Sign Up⤷  Sign Up1.1GTABLET;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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes 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
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Strides Pharma BALSALAZIDE DISODIUM balsalazide disodium TABLET;ORAL 206336-001 Sep 8, 2015 DISCN 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

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 ⤷  Sign Up ⤷  Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up
China 102670626 Balsalazide formulations and manufacture and use thereof ⤷  Sign Up
Japan 2013032395 FORMULATION AND USE OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVE ⤷  Sign Up
South Korea 20090118906 FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES ⤷  Sign Up
Mexico 2009004826 FORMULACIONES Y USOS DE DERIVADOS DE ACIDO 2-HIDROXI-5-FENILAZOBEN ZOICO. (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES.) ⤷  Sign Up
Canada 2668441 PREPARATIONS A BASE DE DERIVES D'ACIDE 2-HYDROXY-5-PHENYLAZOBENZOIQUE ET LEURS APPLICATIONS (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.