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WELCHOL

NDA

COLESEVELAM HYDROCHLORIDE | N022362 | COSETTE PHARMACEUTICALS INC

2 strengths0 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

No clinical trials found on ClinicalTrials.gov for this drug

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

15 letters from Drugs@FDA

Date	Submission	Document
Oct 21, 2021	SUPPL -29	View Letter (PDF)
Jul 30, 2020	SUPPL -28	View Letter (PDF)
May 13, 2020	SUPPL -27	View Letter (PDF)
May 23, 2019	SUPPL -25	View Letter (PDF)
Apr 11, 2019	SUPPL -24	View Letter (PDF)
Jan 22, 2019	SUPPL -23	View Letter (PDF)
Jan 23, 2014	SUPPL -20	View Letter (PDF)
Jul 2, 2013	SUPPL -18	View Letter (PDF)
Jul 2, 2013	SUPPL -15	View Letter (PDF)
Jul 2, 2013	SUPPL -17	View Letter (PDF)
Jul 13, 2012	SUPPL -10	View Letter (PDF)
Jan 17, 2012	SUPPL -9	View Letter (PDF)
Jul 19, 2011	SUPPL -7	View Letter (PDF)
Sep 16, 2010	SUPPL -2	View Letter (PDF)
Oct 26, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Oct 2, 2009

No patent or exclusivity listings for this strength.

#002 — 3.75GM/PACKET

RLDAB

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Oct 2, 2009