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Last Updated: April 18, 2021

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RISEDRONATE SODIUM Drug Profile

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When do Risedronate Sodium patents expire, and what generic alternatives are available?

Risedronate Sodium is a drug marketed by Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex Inc, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Mylan, and Orchid Hlthcare. and is included in fourteen NDAs.

The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Risedronate Sodium

A generic version of RISEDRONATE SODIUM was approved as risedronate sodium by TEVA PHARMS USA on October 5th, 2007.

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Drug patent expirations by year for RISEDRONATE SODIUM
Drug Prices for RISEDRONATE SODIUM

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Recent Clinical Trials for RISEDRONATE SODIUM

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SponsorPhase
Sheffield Children's NHS Foundation TrustPhase 2
TakedaN/A
Chugai PharmaceuticalPhase 3

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Pharmacology for RISEDRONATE SODIUM
Drug ClassBisphosphonate
Medical Subject Heading (MeSH) Categories for RISEDRONATE SODIUM
Paragraph IV (Patent) Challenges for RISEDRONATE SODIUM
Tradename Dosage Ingredient NDA Submissiondate
ATELVIA TABLET, DELAYED RELEASE;ORAL risedronate sodium 022560 2011-06-09
ACTONEL TABLET;ORAL risedronate sodium 020835 2008-08-12
ACTONEL TABLET;ORAL risedronate sodium 020835 2007-09-10
ACTONEL TABLET;ORAL risedronate sodium 020835 2007-09-07
ACTONEL TABLET;ORAL risedronate sodium 020835 2004-04-23

US Patents and Regulatory Information for RISEDRONATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132-001 Oct 5, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132-002 Oct 5, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc RISEDRONATE SODIUM risedronate sodium TABLET, DELAYED RELEASE;ORAL 205066-001 Jun 29, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477-003 Nov 30, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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