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Last Updated: September 26, 2022

RISEDRONATE SODIUM Drug Patent 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 Orbion Pharms. 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. Twelve suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

Drug patent expirations by year 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
Takeda
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 Strength NDA ANDAs Submitted Submissiondate
ATELVIA Delayed-release Tablets risedronate sodium 35 mg 022560 1 2011-06-09
ACTONEL Tablets risedronate sodium 150 mg 020835 1 2008-08-12
ACTONEL Tablets risedronate sodium 75 mg 020835 1 2007-09-07
ACTONEL Tablets risedronate sodium 5 mg, 30 mg and 35 mg 020835 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132-002 Oct 5, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax Labs Inc RISEDRONATE SODIUM risedronate sodium TABLET, DELAYED RELEASE;ORAL 205066-001 Jun 29, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477-003 Nov 30, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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