COLESEVELAM HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for colesevelam hydrochloride and what is the scope of patent protection?
Colesevelam hydrochloride
is the generic ingredient in two branded drugs marketed by Cosette, 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 twenty-one NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for colesevelam hydrochloride. Sixteen suppliers are listed for this compound.
Summary for COLESEVELAM HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 15 |
NDAs: | 21 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 16 |
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 |
Puma Biotechnology, Inc. | Phase 2 |
Pierre Fabre Laboratories | 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 |
US Patents and Regulatory Information for COLESEVELAM HYDROCHLORIDE
Expired US Patents for COLESEVELAM HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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