Colesevelam hydrochloride - Generic Drug Details
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What are the generic sources for colesevelam hydrochloride and what is the scope of freedom to operate?
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 |
| 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 |
US Patents and Regulatory Information for colesevelam hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax | COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 212886-001 | Jan 18, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs Inc | COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 202178-002 | Sep 1, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cosette | WELCHOL | colesevelam hydrochloride | CAPSULE;ORAL | 021141-001 | May 26, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Inventia | COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | TABLET;ORAL | 212050-001 | Dec 4, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | 022362-001 | 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 | BAR, CHEWABLE;ORAL | 210895-001 | Apr 3, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
ISSN: 2162-2639
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