Deep knowledge on
small-molecule drugs and
the 90,000 global patents
covering them

Start your free trial now

Instant access. No credit card. No commitment.

Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Profile for Tradename: ATELVIA

« Back to Dashboard
Atelvia is a drug marketed by Warner Chilcott Llc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-nine patent family members in thirty 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 / Packagers: see list2

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: 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

Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
Status: Completed Condition: 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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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, 2010RXYes7,645,459<disabled>Y<disabled>
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYes7,645,460<disabled>Y<disabled>
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYes8,246,989<disabled>Y<disabled>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

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>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: ATELVIA

Country Document Number Publication Date
Japan2008535912Sep 04, 2008
Canada2602188Oct 13, 2009
Taiwan201138783Nov 16, 2011
TaiwanI351285Nov 01, 2011
San MarinoP200700047Nov 21, 2007
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a free trial or see the plan comparison

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn
`abc