Sevelamer Hydrochloride

Sold as Renagel. Every FDA application for this active ingredient: 2 branded and 6 generic.

As of Nov 15, 2026, FDA lists 8 applications for Sevelamer Hydrochloride (sold as Renagel), first approved Oct 30, 1998, with 4 new uses approved and 0 published complete response letters.

First approved: Oct 30, 1998
Applications: 8
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $865K
First approved in the EU: Jan 28, 2000

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Sevelamer HCl	Part D	$865K	-96%	1,037

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

SEVELAMER 0.8 GM POWDER PACKET: $0.879 per unitGeneric · -32% in a year
SEVELAMER 2.4 GM POWDER PACKET: $0.986 per unitGeneric · -19% in a year
SEVELAMER HCL 800 MG TABLET: $0.684 per unitGeneric · -49% in a year

Approvals in the EU (EMA)

First approved in the EU 15 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

TasermityGenzyme Europe BV · Feb 25, 2015 · lapsed
Renagel, new substanceSanofi Winthrop Industrie · Jan 28, 2000

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension · Duke University	—	Recruiting	Feb 20, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 30, 1998	RenagelNDA 20926 · New molecular entity	Genzyme	6	Discontinued
Jul 12, 2000	RenagelNDA 21179 · New dosage form	Genzyme	13	Marketed
Feb 8, 2019	Sevelamer HydrochlorideANDA 204724	Glenmark Pharms Ltd	0	Marketed
Dec 15, 2020	Sevelamer HydrochlorideANDA 201068	Rising	0	Discontinued
Jun 16, 2021	Sevelamer HydrochlorideANDA 213145	Lupin	0	Marketed
May 26, 2023	Sevelamer HydrochlorideANDA 206883	Macleods Pharms	0	Marketed
Jul 11, 2023	Sevelamer HydrochlorideANDA 212599	Aurobindo Pharma Ltd	0	Marketed
Feb 3, 2025	Sevelamer HydrochlorideANDA 218966	Navinta LLC	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA