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Last Updated: November 5, 2024

RISEDRONATE SODIUM - Generic Drug Details


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What are the generic drug sources for risedronate sodium and what is the scope of freedom to operate?

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, Norvium Bioscience, 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sheffield Children's NHS Foundation TrustPhase 2
Takeda
Chugai PharmaceuticalPhase 3

See all RISEDRONATE SODIUM clinical trials

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
Norvium Bioscience RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477-002 Nov 30, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533-002 Dec 9, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Apotex RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090877-002 Jun 10, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET, DELAYED RELEASE;ORAL 203217-001 May 18, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 079215-001 Jun 13, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 020835-002 Apr 14, 2000 ⤷  Sign Up ⤷  Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ⤷  Sign Up ⤷  Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ⤷  Sign Up ⤷  Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ⤷  Sign Up ⤷  Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ⤷  Sign Up ⤷  Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ⤷  Sign Up ⤷  Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for RISEDRONATE SODIUM

Country Patent Number Title Estimated Expiration
Slovenia 1753395 ⤷  Sign Up
Portugal 2269584 ⤷  Sign Up
European Patent Office 1753395 ENTERIC SOLID ORAL DOSAGE FORM OF A BISPHOSPHONATE CONTAINING A CHELATING AGENT ⤷  Sign Up
Germany 602005022578 ⤷  Sign Up
South Korea 20080083068 ⤷  Sign Up
Argentina 098686 ⤷  Sign Up
Morocco 29681 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.