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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 seven patents protecting this drug and four Paragraph IV challenges.

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

Summary for Tradename: ACTONEL

Suppliers / Packagers: see list27

Pharmacology for Tradename: ACTONEL

Drug ClassBisphosphonate

Clinical Trials for: ACTONEL

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

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

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

Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
Status: Completed Condition: Osteoporosis

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

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 Llc
risedronate sodium
TABLET;ORAL020835-002Apr 14, 2000RXNo6,165,513*PED<disabled>Y<disabled>
Warner Chilcott Llc
risedronate sodium
TABLET;ORAL020835-003May 25, 2002RXYes5,994,329*PED<disabled>Y<disabled>
Warner Chilcott Llc
risedronate sodium
TABLET;ORAL020835-003May 25, 2002RXYes6,432,932*PED<disabled>Y<disabled>
Warner Chilcott
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,465,443*PED<disabled>Y<disabled>
Warner Chilcott Llc
risedronate sodium
TABLET;ORAL020835-004Apr 16, 2007DISCNNo6,165,513*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

Non-Orange Book Patents for Tradename: ACTONEL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety<disabled in preview>
7,410,957Method of treatment using bisphosphonic acid<disabled in preview>
6,544,967 Method for inhibiting bone resorption<disabled in preview>
6,225,294 Method for inhibiting bone resorption<disabled in preview>
6,333,316 Method for inhibiting bone resorption<disabled in preview>
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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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