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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	D. Md.	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

38 trials from ClinicalTrials.gov, 32 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis NCT03984760	Phase 3	Completed	Panion & BF Biotech Inc.	240	2019-06-19 → 2021-02-20
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
The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers NCT00925704	Phase 1	Completed	Shire	41	2009-06-01 → 2009-07-31
Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy NCT03824587	Phase 2/3	Completed	Ardelyx	236	2019-02-28 → 2019-07-17
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients NCT01464190	Phase 3	Completed	Vifor Pharma	659	2011-09 → 2013-04
A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD NCT00785629	N/A	Completed	Denver Nephrologists, P.C.	148	2009-02 → 2011-07
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients NCT01324128	Phase 3	Completed	Vifor Pharma	1,059	2011-03 → 2012-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$5.69

per ea

Lowest NADAC/Unit

$5.69

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
58468013301RENVELA 800 MG TABLET	$5.69	EA	Brand	$0.2285	2026-04-22

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

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

Lowest Price

$1069.71

Highest Price

$1219.35

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
58468-0133-01RENVELA 800MG TAB	$1219.35	FSS	Genzyme Corporation	01/31/2027
58468-0133-01RENVELA 800MG TAB	$1069.71	Big4	Genzyme Corporation	01/31/2027

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

Medicare Part D Spending

CMS annual spending data for Renvela (2024)

Total Spending

$38.0M

Total Claims

27,433

Beneficiaries

8,189

Avg Cost/Unit

$6.39

Spending Trend

$338.9M(2019)→$296.3M(2020)→$193.7M(2021)→$144.3M(2022)→$114.3M(2023)→$38.0M(2024)

YoY Change:-10.1%

5yr CAGR:-1.6%

Source: CMS Medicare Part D Spending by Drug (2024). 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.