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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-six 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 list246
Formulation / Manufacturing:see details

Clinical Trials for: calcium carbonate; risedronate sodium

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

Study Comparing Bone Loss in Women Who Take Calcium and Vitamin D With Women Who Also Take Risedronate or Exercise
Status: Recruiting Condition: Osteopenia.

Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer
Status: Completed Condition: Osteoporosis; Prostate Cancer

Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial CAN-NCIC-MA27
Status: Completed Condition: Breast Cancer; Osteoporosis

Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food
Status: Completed Condition: Healthy

Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
Status: Completed Condition: Hip Fracture

Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density
Status: Terminated Condition: Osteopenia

Courtesy of ClinicalTrials.org
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
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, 2005DISCNNo6,165,513*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, 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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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>
6,544,967 Method for inhibiting bone resorption<disabled in preview>
6,333,316 Method for inhibiting bone resorption<disabled in preview>
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety<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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