Risedronate Sodium

Prevents postmenopausal osteoporosis. Sold as Actonel, Atelvia. Every FDA application for this active ingredient: 2 branded and 14 generic.

As of Nov 15, 2026, FDA lists 16 applications for Risedronate Sodium (sold as Actonel, Atelvia), first approved Mar 27, 1998, with 11 new uses approved and 0 published complete response letters.

First approved: Mar 27, 1998
Applications: 16
New uses approved: 11
Complete response letters: 0
Medicare spending, 2025: $24.4M

Medicare Spending

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


Risedronate Sodium	Part D	$20.5M	-8%	85,096
Risedronate Sodium Dr	Part D	$3.0M	-13%	3,838
Actonel	Part D	$748K	-23%	277
Atelvia	Part D	$135K	-22%	70

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

RISEDRONATE SODIUM 150 MG TAB: $11.02 per unitGeneric · -37% in a year
RISEDRONATE SODIUM 35 MG TAB: $1.47 per unitGeneric · -28% in a year
RISEDRONATE SODIUM 35 MG TABLET: $1.47 per unitGeneric · -28% in a year
RISEDRONATE SODIUM 5 MG TABLET: $1.52 per unitGeneric · -8% in a year
ACTONEL 35 MG TABLET: $81.86 per unitBrand · +0% in a year
ATELVIA DR 35 MG TABLET: $63.81 per unitBrand · +0% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of patients with osteogenesis imperfectaWarner Chilcott Pharmaceuticals · designated Dec 18, 2006 · withdrawn

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Actonel, new approvalDrugs with a new dosage in a new additional dosage form. · Takeda Pharmaceutical Company Limited · Dec 25, 2012
ActonelDrugs with a new indication and a new dosage for the treatment of Paget's disease of bone. · Takeda Pharmacdeutical Co., Ltd. · Jul 16, 2008

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Camrelizumab Plus Risedronate and Chemotherapy for Triple-Negative Breast Cancer: An Exploratory Clinical Study on Mechanisms and EfficacyBreast Cancer Triple Negative Breast Cancer · Harbin Medical University	Phase 2	Active, not recruiting	Mar 13, 2026
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric SurgeryBone Loss · Wake Forest University Health Sciences	Phase 3	Recruiting	Jun 10, 2021
Effects of Bisphosphonates on OI-Related Hearing LossOsteogenesis Imperfecta · Hospital for Special Surgery, New York	Phase 4	Recruiting	Nov 5, 2019

Applications

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


Mar 27, 1998	ActonelNDA 20835 · New molecular entity	Apil	33	Marketed
Oct 5, 2007	Risedronate SodiumANDA 77132	Teva Pharms USA	6	Marketed
Oct 8, 2010	AtelviaNDA 22560 · New dosage form	Apil	9	Marketed
Jun 13, 2014	Risedronate SodiumANDA 79215	Teva Pharms USA	2	Marketed
May 18, 2015	Risedronate SodiumANDA 203217	Teva Pharms USA	0	Marketed
Nov 30, 2015	Risedronate SodiumANDA 90877	Apotex	2	Marketed
Nov 30, 2015	Risedronate SodiumANDA 90886	Sun Pharm	3	Marketed
Nov 30, 2015	Risedronate SodiumANDA 200296	Aurobindo Pharma Ltd	2	Marketed
Nov 30, 2015	Risedronate SodiumANDA 200477	Pharmobedient	1	Discontinued
Oct 21, 2016	Risedronate SodiumANDA 206768	Aurobindo Pharma	0	Marketed
Nov 29, 2016	Risedronate SodiumANDA 203533	Macleods Pharms	4	Marketed
Jun 29, 2018	Risedronate SodiumANDA 205066	Impax Labs Inc	1	Discontinued
Sep 11, 2018	Risedronate SodiumANDA 203822	Zydus Pharms	1	Discontinued
Feb 15, 2019	Risedronate SodiumANDA 207516	Hangzhou Binjiang	0	Discontinued
May 13, 2019	Risedronate SodiumANDA 205280	Orbion Pharms	1	Marketed
Jul 9, 2019	Risedronate SodiumANDA 203925	Sun Pharm	1	Discontinued

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