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Last Updated: November 2, 2024

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
Drug patent expirations by year for COLESEVELAM HYDROCHLORIDE
Recent Clinical Trials for COLESEVELAM HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St. Boniface HospitalPhase 1/Phase 2
Spanish Breast Cancer Research GroupPhase 2
Puma Biotechnology, Inc.Phase 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
Alkem Labs Ltd COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride FOR SUSPENSION;ORAL 210316-001 May 6, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zhejiang Jingxin COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 209946-001 Jul 15, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 209038-001 Oct 5, 2018 AB RX No 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
Glenmark Pharms Ltd COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 203480-001 May 18, 2018 AB 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
Zydus Pharms COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 207765-001 Oct 7, 2019 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

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