Viewing data from:

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Charles R. Nolan, M.D - Citizen Petition FDA-2006-P-0392 · 6 docket documents Charles R. Nolan, M.D., a nephrologist, filed this citizen petition on May 3, 2006, requesting that the FDA withdraw approval of the new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg, manufactured by Genzyme Corporation and indicated for hyperphosphatemia	Other	2009-04-21	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

68 trials from ClinicalTrials.gov, 57 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Dialysis Clinical Outcomes Revisited (DCOR) Trial NCT00324571	Phase 4	Completed	Genzyme, a Sanofi Company	2,000	2001-03 → 2006-02
Regulation of Bone Formation in Renal Osteodystrophy NCT00560300	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	61	2000-11 → 2006-11
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia NCT01850602	Phase 3	Completed	Kissei Pharmaceutical Co., Ltd.	213	2013-04-23 → 2013-12-10
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis NCT00268957	Phase 3	Completed	Genzyme, a Sanofi Company	217	2006-01 → 2007-05
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate NCT00440648	Phase 2	Completed	Genzyme, a Sanofi Company	80	2005-03 → 2006-07
Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease NCT00806481	Phase 2	Completed	University Hospital Birmingham NHS Foundation Trust	120	2009-02 → 2011-10
An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis NCT00681941	Phase 3	Completed	Genzyme, a Sanofi Company	49	2006-01 → 2007-03
Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis NCT01736150	Phase 3	Completed	Genzyme, a Sanofi Company	205	2010-03 → 2010-09
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis NCT03427125	Phase 3	Completed	Ardelyx	1,559	2018-01-08 → 2020-02-27
Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis NCT00710788	N/A	Completed	Azienda Sanitaria ASL Avellino 2	360	2007-01 → 2011-09

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$44.79

Highest Price

$110.43

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00955-1048-18SEVELAMER HCL 800MG TAB	$110.43	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00955-1048-18SEVELAMER HCL 800MG TAB	$44.79	Big4	Sanofi Aventis U.S. LLC	05/31/2028

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

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