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Details for Generic Name: risedronate sodium

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Risedronate sodium is the generic ingredient in three branded drugs marketed by Warner Chilcott Llc, Teva Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, and Sun Pharma Global, and is included in ten NDAs. There are ten patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-one patent family members in thirty-one countries.

There are nineteen drug master file entries for risedronate sodium. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: risedronate sodium

Tradenames:3
Patents:10
Applicants:7
NDAs:10
Drug Master File Entries: see list19
Suppliers / Packaging: see list29
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: risedronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for RISEDRONATE SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL35MG
<disabled><disabled>TABLET;ORAL30MG
<disabled><disabled>TABLET;ORAL35MG

Clinical Trials for: risedronate sodium

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

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

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

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
Apotex Inc
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL090877-003Jun 10, 2014RXNo<disabled><disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008RXYes7,192,938*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 1998RXNo6,165,513*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: risedronate sodium

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 20085,583,122*PED<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835-004Apr 16, 20076,096,342*PED<disabled>
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 20105,583,122*PED<disabled>
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International Patent Family for Ingredient: risedronate sodium

Country Document Number Publication Date
Taiwan201138783Nov 16, 2011
South Korea20070111551Nov 21, 2007
New Zealand551118Sep 30, 2010
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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 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

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