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RENAGEL

NDA

SEVELAMER HYDROCHLORIDE | N021179 | GENZYME CORP

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 Chain10 active DMFs7 inactive

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

SOLARA ACTIVE PHARMA SCIENCES LTDSEVELAMER HYDROCHLORIDE

DMF 211042007

LUPIN MANUFACTURING SOLUTIONS LTDSEVELAMER HYDROCHLORIDE

DMF 214882008

EMCURE PHARMACEUTICALS LTDSEVELAMER HYDROCHLORIDE (PROCESS-I)

DMF 220692008

FORMOSA LABORATORIES INCSEVELAMER HYDROCHLORIDE

DMF 226312009

EMCURE PHARMACEUTICALS LTDSEVELAMER HYDROCHLORIDE (PROCESS II)

DMF 248722011

SUN PHARMACEUTICAL INDUSTRIES LTDSEVELAMER HYDROCHLORIDE

DMF 254342011

NAVINTA LLCSEVELAMER HYDROCHLORIDE

DMF 279082014

APITORIA PHARMA PRIVATE LTDSEVELAMER HYDROCHLORIDE

DMF 310932016

AMI LIFESCIENCES PRIVATE LTDSEVELAMER HYDROCHLORIDE

DMF 380162023

HVL PHARMA UK LIMITEDSEVELAMER HYDROCHLORIDE

DMF 381982023

DOW CHEMICAL COInactiveSEVELAMER HYDROCHLORIDE

DMF 146952000

USV PRIVATE LTDInactiveSEVELAMER HYDROCHLORIDE

DMF 221132008

CHEMO IBERICA SAInactiveSEVELAMER HYDROCHLORIDE

DMF 223492008

DERIVADOS QUIMICOS SA FINE CHEMICALSInactiveSEVELAMER HYDROCHLORIDE

DMF 239392010

MYLAN LABORATORIES LTDInactiveSEVELAMER HYDROCHLORIDE

DMF 255792011

HETERO DRUGS LTDInactiveSEVELAMER HYDROCHLORIDE

DMF 261002012

CTX LIFE SCIENCES PVT LTDInactiveSEVELAMER HYDROCHLORIDE

DMF 274912013

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Apr 2, 2024	SUPPL -39	View Letter (PDF)
May 1, 2020	SUPPL -38	View Letter (PDF)
Feb 22, 2019	SUPPL -37	View Letter (PDF)
Mar 11, 2016	SUPPL -32	View Letter (PDF)
Nov 28, 2014	SUPPL -30	View Letter (PDF)
Jun 24, 2011	SUPPL -29	View Letter (PDF)
Oct 22, 2007	SUPPL -20	View Letter (PDF)
Aug 17, 2007	SUPPL -21	View Letter (PDF)
Jul 26, 2005	SUPPL -15	View Letter (PDF)
Mar 3, 2004	SUPPL -2	View Letter (PDF)
Jul 12, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 400MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 12, 2000

No patent or exclusivity listings for this strength.

#002 — 800MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 12, 2000