COLESEVELAM HYDROCHLORIDE Drug Patent Profile
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Which patents cover Colesevelam Hydrochloride, and when can generic versions of Colesevelam Hydrochloride launch?
Colesevelam Hydrochloride is a drug marketed by Alkem Labs Ltd, Glenmark Pharms Ltd, Impax, Watson Labs Inc, Beijing Tide Pharm, Bionpharma, Chartwell Rx, Dr Reddys, Impax Labs Inc, Invagen Pharms, Inventia, United Res Labs, Zhejiang Jingxin, and Zydus Pharms. and is included in seventeen NDAs.
The generic ingredient in COLESEVELAM HYDROCHLORIDE is colesevelam hydrochloride. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Colesevelam Hydrochloride
A generic version of COLESEVELAM HYDROCHLORIDE was approved as colesevelam hydrochloride by IMPAX LABS INC on May 16th, 2018.
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Summary for COLESEVELAM HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 14 |
NDAs: | 17 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 10 |
Clinical Trials: | 47 |
What excipients (inactive ingredients) are in COLESEVELAM HYDROCHLORIDE? | COLESEVELAM HYDROCHLORIDE excipients list |
DailyMed Link: | COLESEVELAM HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for COLESEVELAM HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
St. Boniface Hospital | Phase 1/Phase 2 |
Spanish Breast Cancer Research Group | Phase 2 |
Puma Biotechnology, Inc. | Phase 2 |
Pharmacology for COLESEVELAM HYDROCHLORIDE
Drug Class | Bile Acid Sequestrant |
Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for COLESEVELAM HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for COLESEVELAM HYDROCHLORIDE
Paragraph IV (Patent) Challenges for COLESEVELAM HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
WELCHOL | Powder for Oral Suspension | colesevelam hydrochloride | 1.875 g/Packet and 3.75 g/Packet | 022362 | 1 | 2010-04-09 |
WELCHOL | Tablets | colesevelam hydrochloride | 625 mg | 021176 | 1 | 2009-07-01 |