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Details for Generic Name: risedronate sodium

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Summary for Generic Name: risedronate sodium

Tradenames:3
Patents:12
Applicants:6
NDAs:7
Drug Master File Entries: see list19
Suppliers: see list4
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;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

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

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
ACTONEL
risedronate sodium
TABLET;ORAL020835Apr 14, 2000RXNo6,165,513*PED<disabled>Y<disabled>
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560Oct 8, 2010RXYes7,645,460<disabled>Y<disabled>
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560Oct 8, 2010RXYes5,622,721<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835Apr 14, 2000RXNo5,583,122*PED<disabled>Y<disabled>
Warner Chilcott Llc
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560Oct 8, 2010RXYes5,583,122*PED<disabled>Y<disabled>
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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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