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Profile for Tradename: ACTONEL

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Actonel is a drug marketed by Warner Chilcott Llc and Warner Chilcott and is included in two NDAs. It is available from four suppliers. There are eight patents protecting this drug and four Paragraph IV challenges.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and thirty-five drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for Tradename: ACTONEL

Suppliers: see list4

Pharmacology for Tradename: ACTONEL

Drug ClassBisphosphonate

Clinical Trials for: ACTONEL

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.

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

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

Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
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

Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
Status: Completed Condition: Osteoporosis

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 to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
Status: Completed Condition: Osteoporosis, Postmenopausal

Courtesy of
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
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823Aug 12, 2005DISCNNo6,165,513*PED<disabled>Y<disabled>
Warner Chilcott Llc
risedronate sodium
TABLET;ORAL020835Apr 22, 2008RXYes7,192,938*PED<disabled>Y<disabled>
Warner Chilcott
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823Aug 12, 2005DISCNNo6,432,932*PED<disabled>Y<disabled>
Warner Chilcott Llc
risedronate sodium
TABLET;ORAL020835Apr 16, 2007DISCNNo6,165,513*PED<disabled>Y<disabled>
Warner Chilcott Llc
risedronate sodium
TABLET;ORAL020835May 25, 2002RXYes6,465,443*PED<disabled>Y<disabled>
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Paragraph IV activity for: ACTONEL

Drugname Dosage Strength RLD Submissiondate
risedronate sodiumTablets150 mgActonel8/12/2008
risedronate sodium with calcium carbonateTablets35 mg; 500 mgActonel with Calcium12/18/2007
risedronate sodiumTablets75 mgActonel9/10/2007
risedronate sodiumTablets5 mg, 30 mg and 35 mgActonel4/23/2004
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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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