TheraRadar
Data updated: May 26, 2026

ATELVIA (risedronate sodium)

Musculoskeletal Approved 2010-10-08

Atelvia is a delayed-release medication used for postmenopausal women who have osteoporosis. It helps patients with this condition by reducing the risk of both spinal and other types of bone fractures. Because the ideal length of time to take this drug is not yet known, healthcare providers regularly re-evaluate the need for continued use and may suggest stopping therapy after three to five years for those at low risk of fracture.

How ATELVIA Works

This drug works by binding to hydroxyapatite crystals within the bone to act as an antiresorptive agent. It specifically targets and inhibits osteoclasts, the cells responsible for breaking down bone tissue, which reduces the overall rate of bone turnover.

1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Prescription
First Approved
2010-10-08
Patent Cliff
2028

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Routes
ORAL
Dosage Forms
TABLET, DELAYED RELEASE

Companies

Active Ingredient: RISEDRONATE SODIUM

ATELVIA Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2010 to 2026
Feb 2026 SUPPL
Label · Labeling
Aug 2020 SUPPL
Label · Labeling
Apr 2015 SUPPL
Label · Labeling

What ATELVIA Treats

1 indications

ATELVIA is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Osteoporosis
Source: FDA Label

ATELVIA Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03208582 BAMES SCH-2013 Ph 2 completed Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta?
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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ATELVIA FDA Label Details

Indications & Usage

FDA Label (PDF)

ATELVIA is indicated for the treatment of Osteoporosis.

View full patent landscape →
3 OB patents · 2 families · 38 international docs across 16 countries

ATELVIA Patents & Exclusivity

Latest Patent: Jan 2028

Patents (3 active)

US7645460 Expires Jan 9, 2028
US7645459 Expires Jan 9, 2028
US8246989 Expires Jan 16, 2026
Source: FDA Orange Book

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Revenue Insights

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  • Historical trend analysis

Patent Timeline

  • Cliff: 2028
  • 3 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.