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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 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

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;ORAL020835-005Apr 22, 2008RXYes7,718,634*PED<disabled>Y<disabled>
Warner Chilcott
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,165,513*PED<disabled>Y<disabled>
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, 2002RXYes6,165,513*PED<disabled>Y<disabled>
Warner Chilcott Llc
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008RXYes6,165,513*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
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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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