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Last Updated: October 7, 2024

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

SponsorPhase
St. Boniface HospitalPhase 1/Phase 2
Puma Biotechnology, Inc.Phase 2
Pierre Fabre LaboratoriesPhase 2

See all COLESEVELAM HYDROCHLORIDE clinical trials

Pharmacology for COLESEVELAM HYDROCHLORIDE
Drug ClassBile Acid Sequestrant
Mechanism of ActionBile-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
Bionpharma COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 208670-001 Sep 13, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride FOR SUSPENSION;ORAL 202190-001 Jul 16, 2018 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Beijing Tide Pharm COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 206036-001 Oct 14, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette WELCHOL colesevelam hydrochloride BAR, CHEWABLE;ORAL 210895-001 Apr 3, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 091600-001 May 16, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 203480-001 May 18, 2018 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 022362-002 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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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.