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Profile for Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

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Actonel With Calcium (copackaged) is a drug marketed by Warner Chilcott and is included in one NDA. There are five patents protecting this drug.

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

Summary for Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

Patents:5
Applicants:1
NDAs:1
Formulation / Manufacturing:see details

Clinical Trials for: ACTONEL WITH CALCIUM (COPACKAGED)

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,465,443*PED<disabled>Y<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,015,801*PED<disabled>Y<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,432,932*PED<disabled>Y<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,165,513*PED<disabled>Y<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo5,994,329*PED<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

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
6,544,967 Method for inhibiting bone resorption<disabled in preview>
6,225,294 Method for inhibiting bone resorption<disabled in preview>
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety<disabled in preview>
6,333,316 Method for inhibiting bone resorption<disabled in preview>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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