BALSALAZIDE DISODIUM Drug Patent Profile
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Which patents cover Balsalazide Disodium, and when can generic versions of Balsalazide Disodium launch?
Balsalazide Disodium is a drug marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus, and Strides Pharma. and is included in five NDAs.
The generic ingredient in BALSALAZIDE DISODIUM is balsalazide disodium. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Balsalazide Disodium
A generic version of BALSALAZIDE DISODIUM was approved as balsalazide disodium by APOTEX INC on December 28th, 2007.
Summary for BALSALAZIDE DISODIUM
US Patents: | 0 |
Applicants: | 5 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 221 |
Clinical Trials: | 7 |
Patent Applications: | 4,241 |
Drug Prices: | Drug price information 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
Sponsor | Phase |
---|---|
Valeant Pharmaceuticals International, Inc. | Phase 3 |
Bausch Health Americas, Inc. | Phase 3 |
Roxane Laboratories | N/A |
Pharmacology for BALSALAZIDE DISODIUM
Drug Class | Aminosalicylate |
Anatomical Therapeutic Chemical (ATC) Classes for BALSALAZIDE DISODIUM
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 |