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RENVELA

NDA

SEVELAMER CARBONATE | N022127 | SANOFI GENZYME

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Genzyme Corporation v. Endo Pharmaceuticals Inc. 1:2011cv01103 1 patentANDA 202616sevelamer carbonate	MDD	2011-04-27	Terminated 2012-09-25	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Renvela (2023)

Total Spending

$114.3M

Total Claims

69,891

Beneficiaries

16,562

Avg Cost/Unit

$7.10

Spending Trend

$338.9M(2019)→$296.3M(2020)→$193.7M(2021)→$144.3M(2022)→$114.3M(2023)

YoY Change:+0.6%

5yr CAGR:+2.8%

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

API Supply Chain14 active DMFs6 inactive

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

LUPIN MANUFACTURING SOLUTIONS LTDSEVELAMER CARBONATE

DMF 222932008

SOLARA ACTIVE PHARMA SCIENCES LTDSEVELAMER CARBONATE

DMF 229402009

FORMOSA LABORATORIES INCSEVELAMER CARBONATE

DMF 230392009

EMCURE PHARMACEUTICALS LTDSEVELAMER CARBONATE (FOR POWDER FORMULATION)

DMF 234592010

SUN PHARMACEUTICAL INDUSTRIES LTDSEVELAMER CARBONATE

DMF 245872011

EMCURE PHARMACEUTICALS LTDSEVELAMER CARBONATE (PROCESS II)

DMF 250392011

MATRIX PHARMACORP PRIVATE LTDSEVELAMER CARBONATE

DMF 256392011

NAVINTA LLCSEVELAMER CARBONATE

DMF 274052014

APITORIA PHARMA PRIVATE LTDSEVELAMER CARBONATE

DMF 279262014

FORMOSA LABORATORIES INCSEVELAMER CARBONATE

DMF 300022015

HETERO DRUGS LTDSEVELAMER CARBONATE

DMF 305692016

SHANDONG XINHUA PHARMACEUTICAL CO LTDSEVELAMER CARBONATE

DMF 353262020

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDSEVELAMER CARBONATE

DMF 369292022

AMI LIFESCIENCES PRIVATE LTDSEVELAMER CARBONATE

DMF 379812023

CHEMO IBERICA SA MADRIDInactiveSEVELAMER CARBONATE

DMF 222622008

EMCURE PHARMACEUTICALS LTDInactiveSEVELAMER CARBONATE (E SUB)

DMF 231642009

CHEMO IBERICA SAInactiveSEVELAMER CARBONATE

DMF 233882009

USV LTDInactiveSEVELAMER CARBONATE

DMF 253572011

HETERO DRUGS LTDInactiveSEVELAMER CARBONATE

DMF 262062012

CTX LIFE SCIENCES PVT LTDInactiveSEVELAMER CARBONATE

DMF 282992014

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 7, 2023	SUPPL -21	View Letter (PDF)
May 1, 2020	SUPPL -19	View Letter (PDF)
Nov 28, 2016	SUPPL -15	View Letter (PDF)
Mar 11, 2016	SUPPL -13	View Letter (PDF)
Nov 28, 2014	SUPPL -11	View Letter (PDF)
Jun 24, 2011	SUPPL -8	View Letter (PDF)
Oct 22, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 800MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 19, 2007

No patent or exclusivity listings for this strength.