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Risedronate sodium - Generic Drug Details

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Risedronate sodium is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Macleods Pharms Ltd, Apil, Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, and Aurobindo Pharma Ltd, and is included in ten 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 two hundred and fifty-three patent family members in fifty-two countries.

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

Summary for Generic Name: risedronate sodium

Tradenames:3
Patents:10
Applicants:7
NDAs:10
Drug Master File Entries: see list19
Suppliers / Packaging: see list10
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;ORAL30MG
<disabled><disabled>TABLET;ORAL35MG

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
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010RXYes7,645,459<disabled>Y <disabled>
Aurobindo Pharma Ltd
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL200296-002Nov 30, 2015RXNo<disabled><disabled>
Apotex Inc
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL090877-002Jun 10, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: risedronate sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 20105,583,122*PED<disabled>
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 19985,583,122*PED<disabled>
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 20005,583,122*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: 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
6,333,316 Method for inhibiting bone resorption<disabled in preview>
8,535,718Dosage forms of bisphosphonates<disabled in preview>
8,409,614Low dosage forms of risedronate or its salts<disabled in preview>
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International Patent Family for Ingredient: risedronate sodium

Country Document Number Estimated Expiration
South Korea101280138<disabled in preview>
South Korea20090029312<disabled in preview>
Canada2481142<disabled in preview>
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Supplementary Protection Certificates for Tradename: RISEDRONATE SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006002Lithuania<disabled>PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
222Luxembourg<disabled>91222, EXPIRES: 20200824
2007007Lithuania<disabled>PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
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