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Last Updated: December 11, 2019

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Balsalazide disodium - Generic Drug Details

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What are the generic 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, Mylan, West-ward Pharms Int, 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

See drug prices for balsalazide disodium

Recent Clinical Trials for balsalazide disodium

Identify potential brand extensions & 505(b)(2) entrants

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

See all balsalazide disodium clinical trials

Recent Litigation for balsalazide disodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
Salix Pharmaceuticals, Inc. v. Apotex, Inc.2015-09-30
Salix Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc.2014-07-17

See all balsalazide disodium litigation

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
Apotex Inc BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883-001 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
>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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
McKinsey
Harvard Business School
Moodys
Johnson and Johnson

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