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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, Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, Teva Pharms, and Teva Pharms Usa, and is included in seven 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 sixty-eight patent family members in twenty-nine countries.

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

Summary for Generic Name: risedronate sodium

Tradenames:3
Patents:10
Applicants:6
NDAs:7
Drug Master File Entries: see list19
Suppliers: see list4
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

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;ORAL5MG
<disabled><disabled>TABLET;ORAL30MG

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: 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

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

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

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
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008RXYes7,718,634*PED<disabled>Y<disabled>
Apotex Inc
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL090877-003Jun 10, 2014RXNo<disabled><disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002RXYes6,465,443*PED<disabled>Y<disabled>
Teva Pharms
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL077132-002Oct 5, 2007RXNo<disabled><disabled>
Apotex Inc
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL090877-002Jun 10, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: risedronate sodium

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)2010014765Feb 04, 2010
South Korea101280138Jun 28, 2013
Morocco29681Aug 01, 2008
Japan2011529902Dec 15, 2011
World Intellectual Property Organization (WIPO)2005115331Jan 19, 2006
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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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