You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

COLESEVELAM HYDROCHLORIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Recent Clinical Trials for COLESEVELAM HYDROCHLORIDE

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

SponsorPhase
Spanish Breast Cancer Research GroupPhase 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
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
United Res Labs COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 213456-001 Jan 21, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 207765-001 Oct 7, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride FOR SUSPENSION;ORAL 212886-001 Jan 18, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride TABLET;ORAL 200830-001 Sep 2, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride FOR SUSPENSION;ORAL 210316-001 May 6, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ⤷  Try a Trial ⤷  Try a Trial
Cosette WELCHOL colesevelam hydrochloride BAR, CHEWABLE;ORAL 210895-001 Apr 3, 2019 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.