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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-three drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for Tradename: ACTONEL

Patents:8
Applicants:2
NDAs:2
Suppliers: see list4

Pharmacology for Tradename: ACTONEL

Ingredient-typeDiphosphonates
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.

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

Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
Status: Completed Condition: Postmenopausal

Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
Status: Completed Condition: Bone Loss

A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Status: Recruiting Condition: Involutional Osteoporosis

Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
Status: Completed Condition: Osteoporosis

Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
Status: Completed Condition: Breast Cancer; Osteoporosis

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;ORAL020835May 25, 2002RXYes6,465,443*PED<disabled>Y<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823Aug 12, 2005DISCNNo5,583,122*PED<disabled>Y<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823Aug 12, 2005DISCNNo6,465,443*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835Apr 22, 2008RXYes6,165,513*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835May 25, 2002RXYes5,583,122*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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