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Profile for Tradename: ATELVIA

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Atelvia is a drug marketed by Warner Chilcott Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-six patent family members in twenty-nine countries.

The generic ingredient in ATELVIA is risedronate sodium. There are nineteen drug master file entries for this compound. Four suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the risedronate sodium profile page.

Summary for Tradename: ATELVIA

Patents:3
Applicants:1
NDAs:1
Suppliers: see list1

Pharmacology for Tradename: ATELVIA

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: ATELVIA

Study Comparing Bone Loss in Women Who Take Calcium and Vitamin D With Women Who Also Take Risedronate or Exercise
Status: Not yet recruiting Condition: Osteopenia.

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
Status: Completed Condition: Osteoporosis

A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Status: Active, not recruiting Condition: Involutional Osteoporosis

Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
Status: Completed Condition: Prostate Cancer

Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate
Status: Completed Condition: Bioavailability

Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
Status: Completed Condition: Postmenopausal

A Study of Actonel for the Prevention of Bone Loss
Status: Completed Condition: Leukemia; Lymphoma

A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Status: Active, not recruiting Condition: Involutional Osteoporosis

Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
Status: Completed Condition: Bone Loss

Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
Status: Completed Condition: Osteoporosis, Postmenopausal; Back Pain; Spinal Fracture

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYes8,246,989<disabled>Y<disabled>
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYes7,645,459<disabled>Y<disabled>
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYes7,645,460<disabled>Y<disabled>
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Paragraph IV activity for: ATELVIA

Drugname Dosage Strength RLD Submissiondate
risedronate sodiumDelayed-release Tablets35 mgAtelvia7/19/2011

Non-Orange Book Patents for Tradename: ATELVIA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,409,614Low dosage forms of risedronate or its salts<disabled in preview>
8,535,718Dosage forms of bisphosphonates<disabled in preview>
8,409,615Low dosage forms of risedronate or its salts<disabled in preview>
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International Patent Family for Tradename: ATELVIA

Country Document Number Publication Date
New Zealand587774Mar 30, 2012
World Intellectual Property Organization (WIPO)2010014766Feb 04, 2010
Japan2011529902Dec 15, 2011
Russian Federation2007136046May 20, 2009
Argentina049022Jun 21, 2006
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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