DrugPatentWatch Database Preview➤ Subscribe for complete access
« Back to Dashboard
Balsalazide disodiumis 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. 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:||191|
|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|
|Bausch Health Americas, Inc.||Phase 3|
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 for a Free Trial||⤷ Sign up for a Free Trial|
|Valeant Pharms Intl||GIAZO||balsalazide disodium||TABLET;ORAL||022205-001||Feb 3, 2012||⤷ Sign up for a Free Trial||⤷ Sign up for a Free Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|Country||Patent Number||Estimated Expiration|
|World Intellectual Property Organization (WIPO)||2011137103||⤷ Sign up for a Free Trial|
|Denmark||2096912||⤷ Sign up for a Free Trial|
|Brazil||PI0615195||⤷ Sign up for a Free Trial|
|European Patent Office||2563117||⤷ Sign up for a Free Trial|
|Canada||2797560||⤷ Sign up for a Free Trial|
|>Country||>Patent Number||>Estimated Expiration|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.