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Last Updated: March 28, 2024

Risedronate sodium - Generic Drug Details


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What are the generic sources for risedronate sodium and what is the scope of patent protection?

Risedronate sodium is the generic ingredient in three branded drugs marketed by Apil, Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Mylan, and Orbion Pharms, and is included in sixteen NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risedronate sodium has eighty-four patent family members in thirty-three countries.

There are seventeen drug master file entries for risedronate sodium. Thirteen suppliers are listed for this compound.

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
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
Orbion Pharms RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 205280-002 May 13, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477-003 Nov 30, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477-005 Jun 10, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hangzhou Binjiang RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 207516-001 Feb 15, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533-003 Nov 29, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET, DELAYED RELEASE;ORAL 203217-001 May 18, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for risedronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for risedronate sodium

Country Patent Number Title Estimated Expiration
European Patent Office 2283825 Formes orales entériques solides de dosage d'un diphosphonate avec un agent chélatant (Enteric solid oral dosage form of a bisphosphonate containing a chelating agent) ⤷  Try a Trial
San Marino AP200700047 Forme di dosaggio di risedronato ⤷  Try a Trial
Russian Federation 2359678 ЛЕКАРСТВЕННЫЕ ФОРМЫ НА ОСНОВЕ БИСФОСФОНАТОВ (MEDICINAL FORMS ON BASIS OF BIPHOSPHONATES) ⤷  Try a Trial
South Korea 20070015596 ENTERIC SOLID ORAL DOSAGE FORM OF BISPHOSPHONATE CONTAINING A CHELATING AGENT ⤷  Try a Trial
European Patent Office 2269584 Formes orales entériques solides de dosage d'un diphosphonate avec un agent chelatant (Enteric solid oral dosage form of a bisphosphonate containing a chelating agent) ⤷  Try a Trial
South Africa 200609446 Enteric solid oral dosage form of bisphosphonate containing a chelating agent ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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