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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. Eleven 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 list11
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
Aurobindo Pharma Ltd
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL200296-001Nov 30, 2015RXNo
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-004Apr 16, 2007DISCNNo6,165,513*PEDDec 10, 2018Y
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002RXYes6,432,932*PEDJan 17, 2019Y
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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
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 19985,583,122*PED<disabled>
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 20006,096,342*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
8,535,718Dosage forms of bisphosphonates<disabled in preview>
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety<disabled in preview>
6,225,294 Method for inhibiting bone resorption<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: risedronate sodium

Country Document Number Estimated Expiration
New Zealand530113<disabled in preview>
World Intellectual Property Organization (WIPO)2010014765<disabled in preview>
Russian Federation2004129324<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RISEDRONATE SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2006002,C0998292Lithuania<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
1175904/01Switzerland<disabled>FORMER OWNER: SCHERING CORPORATION, US
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