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Details for Generic Name: risedronate sodium

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Risedronate sodium is the generic ingredient in three branded drugs marketed by Warner Chilcott Llc, Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, Teva Pharms, and Teva Pharms Usa, and is included in seven NDAs. There are twelve patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for risedronate sodium. Four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: risedronate sodium

Tradenames:3
Patents:12
Applicants:6
NDAs:7
Drug Master File Entries: see list19
Suppliers: see list4
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: risedronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for RISEDRONATE SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL35MG
<disabled><disabled>TABLET;ORAL5MG
<disabled><disabled>TABLET;ORAL30MG

Clinical Trials for: risedronate sodium

Study Comparing Bone Loss in Women Who Take Calcium and Vitamin D With Women Who Also Take Risedronate or Exercise
Status: Not yet recruiting Condition: Osteopenia.

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
Status: Completed Condition: Osteoporosis

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

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

Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
Status: Completed Condition: Bone Loss

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835Apr 22, 2008RXYes5,583,122*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835Apr 22, 2008RXYes7,718,634*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835Apr 16, 2007DISCNNo6,165,513*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835Apr 22, 2008RXYes7,192,938*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835May 25, 2002RXYes6,165,513*PED<disabled>Y<disabled>
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