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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, Teva Pharms Usa, Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, and Teva Pharms, and is included in eight NDAs. There are ten patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-eight patent family members in twenty-nine countries.

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

Summary for Generic Name: risedronate sodium

Tradenames:3
Patents:10
Applicants:6
NDAs:8
Drug Master File Entries: see list19
Suppliers / Packaging: see list29
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

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

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;ORAL020835-005Apr 22, 2008RXYes7,192,938*PED<disabled>Y<disabled>
Teva Pharms Usa
RISEDRONATE SODIUM
risedronate sodium
TABLET, DELAYED RELEASE;ORAL203217-001May 18, 2015RXNo<disabled><disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002RXYes6,465,443*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008RXYes6,165,513*PED<disabled>Y<disabled>
Warner Chilcott Llc
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002RXYes6,015,801*PED<disabled>Y<disabled>
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International Patent Family for Ingredient: risedronate sodium

Country Document Number Publication Date
European Patent Office1753395Feb 21, 2007
South Korea20110002887Jan 10, 2011
China102225047Sep 18, 2013
Norway20065969Feb 23, 2007
Portugal1753395Oct 21, 2010
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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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