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Last Updated: February 3, 2023

Balsalazide disodium - Generic Drug Details


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What are the generic drug sources for balsalazide disodium and what is the scope of freedom to operate?

Balsalazide disodium is the generic ingredient in three branded drugs marketed by Apotex Inc, Hikma, Mylan, Valeant Pharms Intl, and Strides Pharma, and is included in six 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-seven patent family members in twelve countries.

There are ten drug master file entries for balsalazide disodium. Seven 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
See Plans and PricingSee Plans and Pricing1.1GMTABLET;ORAL
See Plans and PricingSee Plans and Pricing1.1GTABLET;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
Mylan BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex Inc BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883-001 Dec 28, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for balsalazide disodium

Country Patent Number Title Estimated Expiration
China 103948609 Balsalazide formulations and manufacture and use thereof See Plans and Pricing
European Patent Office 2563117 FORMULATIONS ET UTILISATIONS DE DÉRIVÉS D'ACIDE 2-HYDROXY-5-PHÉNYLAZOBENZOÏQUE POUR LE TRAITEMENT DE SUJETS MÂLES (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES FOR THE TREATMENT OF MALES) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011137103 See Plans and Pricing
China 102670626 Balsalazide formulations and manufacture and use thereof See Plans and Pricing
Israel 225695 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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