COLESEVELAM HYDROCHLORIDE Drug Patent Profile

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. Fifteen 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 16^th, 2018.

Summary for COLESEVELAM HYDROCHLORIDE

US Patents:	0
Applicants:	14
NDAs:	17
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	46
Formulation / Manufacturing:	see details
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
Spanish Breast Cancer Research Group	Phase 2
Puma Biotechnology, Inc.	Phase 2
Pierre Fabre Laboratories	Phase 2

See all COLESEVELAM HYDROCHLORIDE clinical trials

Pharmacology for COLESEVELAM HYDROCHLORIDE

Drug Class	Bile Acid Sequestrant
Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for COLESEVELAM HYDROCHLORIDE

Anticholesteremic Agents

Anatomical Therapeutic Chemical (ATC) Classes for COLESEVELAM HYDROCHLORIDE

C10AC	Bile acid sequestrants
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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
Zhejiang Jingxin	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	209946-001	Jul 15, 2020	AB	RX	No	No
Alkem Labs Ltd	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	209038-001	Oct 5, 2018	AB	RX	No	No
Impax	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	FOR SUSPENSION;ORAL	212886-001	Jan 18, 2023	AB	RX	No	No
Glenmark Pharms Ltd	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	203480-001	May 18, 2018	AB	RX	No	No
Beijing Tide Pharm	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	206036-001	Oct 14, 2021	AB	RX	No	No
Zydus Pharms	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	207765-001	Oct 7, 2019	AB	RX	No	No