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RENAGEL

NDA

SEVELAMER HYDROCHLORIDE | N020926 | GENZYME CORP

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Renagel (2023)

Total Spending

$49K

Total Claims

Beneficiaries

Avg Cost/Unit

$6.56

Spending Trend

$8.2M(2019)→$3.3M(2020)→$2.3M(2021)→$641K(2022)→$49K(2023)

YoY Change:+2.8%

5yr CAGR:-1.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

3 letters from Drugs@FDA

Date	Submission	Document
Mar 3, 2004	SUPPL -6	View Letter (PDF)
May 5, 2000	SUPPL -2	View Letter (PDF)
Oct 30, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 403MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 30, 1998

No patent or exclusivity listings for this strength.