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Details for Generic Name: calcium carbonate; risedronate sodium

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Calcium carbonate; risedronate sodium is the generic ingredient in one branded drug marketed by Warner Chilcott and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are two hundred and forty-nine drug master file entries for calcium carbonate; risedronate sodium.

Summary for Generic Name: calcium carbonate; risedronate sodium

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list249

Clinical Trials for: calcium carbonate; risedronate sodium

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, 2005DISCNNo5,994,329*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>
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Expired Orange Book Patents for Generic Ingredient: calcium carbonate; risedronate sodium

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 20055,583,122*PED<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 20056,096,342*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: calcium carbonate; risedronate sodium

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
6,225,294 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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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