Colesevelam hydrochloride - Generic Drug Details

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
Pierre Fabre Laboratories	Phase 2
Spanish Breast Cancer Research Group	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
Chartwell Rx	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	201354-001	Dec 17, 2020		DISCN	No	No
Glenmark Pharms Ltd	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	203480-001	May 18, 2018	AB	RX	No	No
Zydus Pharms	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	207765-001	Oct 7, 2019	AB	RX	No	No
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009		DISCN	Yes	No
Alkem Labs Ltd	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	209038-001	Oct 5, 2018	AB	RX	No	No
Bionpharma	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	208670-001	Sep 13, 2019	AB	RX	No	No
Watson Labs Inc	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	FOR SUSPENSION;ORAL	202178-002	Sep 1, 2020		DISCN	No	No

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
Cosette	WELCHOL	colesevelam hydrochloride	CAPSULE;ORAL	021141-001	May 26, 2000
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009