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WELCHOL

NDA

COLESEVELAM HYDROCHLORIDE | N021176 | COSETTE PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

45 trials from ClinicalTrials.gov, 42 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes NCT00147745	Phase 2	Completed	Daiichi Sankyo	36	2005-06 → 2008-01
Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus NCT00361153	Phase 2	Completed	Daiichi Sankyo	35	2006-05 → 2007-03
Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?NCT00911612	Phase 2	Completed	Mayo Clinic	24	2009-01 → 2009-05
Colesevelam for Children With Type 2 Diabetes NCT01258075	Phase 4	Completed	Daiichi Sankyo	236	2011-02-24 → 2020-04-21
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.NCT00754507	Phase 4	Completed	Daiichi Sankyo	65	2002-11 → 2005-04
Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin NCT00484419	Phase 3	Completed	Daiichi Sankyo	169	2007-05 → 2008-04
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol NCT00754039	Phase 4	Completed	Daiichi Sankyo	129	2003-02 → 2004-03
Randomized Trial Comparing Colesevelam vs. Ezetimibe NCT02682680	Phase 4	Completed	LMC Diabetes & Endocrinology Ltd.	200	2016-01-11 → 2017-05-25
Mechanisms of Glucose Lowering Effect of Colesevelam HCl NCT00596427	N/A	Completed	Carine Beysen	60	2007-11 → 2009-04
A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia NCT00690937	Phase 2	Completed	Genzyme, a Sanofi Company	120	2008-02 → 2008-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$5.67

per ea

Lowest NADAC/Unit

$0.2705

per ea

Brand NDCs

Generic NDCs

Avg Brand: $5.67

Avg Generic: $0.2705

95% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00713087981WELCHOL 625 MG TABLET	$5.67	EA	Brand	$0.2705	2026-07-01
00713093681COLESEVELAM 625 MG TABLET	$0.2705	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$510.19

Highest Price

$510.19

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00713-0879-81WELCHOL 625MG TAB	$510.19	FSS	Cosette Pharmaceutical, Inc.	08/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain8 active DMFs4 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

FORMOSA LABORATORIES INCCOLESEVELAM HYDROCHLORIDE

DMF 228702009

SOLARA ACTIVE PHARMA SCIENCES LTDCOLESEVELAM HYDROCHLORIDE

DMF 233782009

EMCURE PHARMACEUTICALS LTDCOLESEVELAM HYDROCHLORIDE

DMF 269342013

PATHEON AUSTRIA GMBH AND CO KGCOLESEVELAM HYDROCHLORIDE

DMF 289452014

FORMOSA LABORATORIES INCCOLESEVELAM HYDROCHLORIDE

DMF 300012015

APITORIA PHARMA PRIVATE LTDCOLESEVELAM HYDROCHLORIDE

DMF 310952016

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDCOLESEVELAM HYDROCHLORIDE

DMF 374312022

NAVINTA LLCCOLESEVELAM HYDROCHLORIDE

DMF 386052023

LUPIN LTDInactiveCOLESEVELAM HYDROCHLORIDE

DMF 233332010

USV LTDInactiveCOLESEVELAM HYDROCHLORIDE

DMF 256962012

IND SWIFT LABORATORIES LTDInactiveCOLESEVELAM HYDROCHLORIDE

DMF 268132013

CTX LIFE SCIENCES PVT LTDInactiveCOLESEVELAM HYDROCHLORIDE

DMF 274922013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

24 letters from Drugs@FDA

Date	Submission	Document
Oct 21, 2021	SUPPL -49	View Letter (PDF)
Jul 30, 2020	SUPPL -48	View Letter (PDF)
May 13, 2020	SUPPL -47	View Letter (PDF)
May 16, 2019	SUPPL -45	View Letter (PDF)
Jan 22, 2019	SUPPL -44	View Letter (PDF)
Jan 23, 2014	SUPPL -37	View Letter (PDF)
Jul 2, 2013	SUPPL -38	View Letter (PDF)
Jul 2, 2013	SUPPL -34	View Letter (PDF)
Jul 13, 2012	SUPPL -30	View Letter (PDF)
Jan 17, 2012	SUPPL -29	View Letter (PDF)
Jul 19, 2011	SUPPL -28	View Letter (PDF)
Sep 16, 2010	SUPPL -27	View Letter (PDF)
Oct 26, 2009	SUPPL -22	View Letter (PDF)
Jun 6, 2008	SUPPL -21	View Letter (PDF)
Jan 23, 2008	SUPPL -17	View Letter (PDF)
Aug 30, 2007	SUPPL -19	View Letter (PDF)
Sep 18, 2006	SUPPL -14	View Letter (PDF)
Jul 13, 2006	SUPPL -15	View Letter (PDF)
Jun 30, 2004	SUPPL -4	View Letter (PDF)
Jun 30, 2004	ORIG -1	View Letter (PDF)
Nov 25, 2003	SUPPL -10	View Letter (PDF)
Oct 16, 2003	SUPPL -9	View Letter (PDF)
Aug 28, 2003	SUPPL -8	View Letter (PDF)
Oct 17, 2002	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 625MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 26, 2000

No patent or exclusivity listings for this strength.