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Balsalazide disodiumis the generic ingredient in three branded drugs marketed by Apotex Inc, Hikma Pharms, 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. Six suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for balsalazide disodium
|Drug Master File Entries:||10|
|Finished Product Suppliers / Packagers:||6|
|Raw Ingredient (Bulk) Api Vendors:||181|
|Drug Prices:||Drug price trends for balsalazide disodium|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for balsalazide disodium|
|What excipients (inactive ingredients) are in balsalazide disodium?||balsalazide disodium excipients list|
|DailyMed Link:||balsalazide disodium at DailyMed|
Recent Clinical Trials for balsalazide disodium
Identify potential brand extensions & 505(b)(2) entrants
|Valeant Pharmaceuticals International, Inc.||Phase 3|
|Mylan Pharmaceuticals||Phase 1|
Generic filers with tentative approvals for BALSALAZIDE DISODIUM
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 Class||Aminosalicylate |
|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||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Valeant Pharms Intl||GIAZO||balsalazide disodium||TABLET;ORAL||022205-001||Feb 3, 2012||⤷ Free Forever Trial||⤷ Free Forever Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|Country||Patent Number||Estimated Expiration|
|China||101610670||⤷ Free Forever Trial|
|European Patent Office||2563117||⤷ Free Forever Trial|
|South Korea||20090118906||⤷ Free Forever Trial|
|Canada||3004028||⤷ Free Forever Trial|
|Brazil||PI0717859||⤷ Free Forever Trial|
|Japan||2015108021||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
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