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Last Updated: July 13, 2020

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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 Par Pharm Inc, 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

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SponsorPhase
Valeant Pharmaceuticals International, Inc.Phase 3
Roxane LaboratoriesN/A
Mylan PharmaceuticalsPhase 1

See all balsalazide disodium clinical trials

Generic filers with tentative approvals for BALSALAZIDE DISODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.1GMTABLET;ORAL
  Start Trial  Start 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 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
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077807-001 Dec 28, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077806-001 Dec 28, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Merck
Harvard Business School
Mallinckrodt
Boehringer Ingelheim

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.