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Last Updated: October 6, 2022

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 Inc, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Mylan, and Orbion Pharms, and is included in sixteen NDAs. There are five patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risedronate sodium has one hundred and fifty-two patent family members in thirty-six countries.

There are seventeen drug master file entries for risedronate sodium. Twelve 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
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
Sun Pharm RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090886-005 Jun 10, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200296-002 Nov 30, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200296-001 Nov 30, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200296-003 Nov 30, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 206768-001 Oct 21, 2016 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 079215-001 Jun 13, 2014 AB RX 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

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

International Patents for risedronate sodium

Country Patent Number Title Estimated Expiration
Mexico PA04009586 ACIDOS BISFOSFONICOS PARA EL TRATAMIENTO Y PREVENCION DE LA OSTEOPOROSIS. (BISPHOSPHONIC ACID FOR THE TREATMENT AND PREVENTION OF OSTEOPOROSIS.) See Plans and Pricing
Hong Kong 1161130 ENTERIC SOLID ORAL DOSAGE FORM OF BISPHOSPHONATE CONTAINING A CHELATING AGENT See Plans and Pricing
Cyprus 1108105 See Plans and Pricing
China 1939314 Ibandronic acid for the treatment and prevention of osteoporosis See Plans and Pricing
Cyprus 1116233 See Plans and Pricing
Japan 2011529901 See Plans and Pricing
Germany 60317061 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
McKesson
Express Scripts
Johnson and Johnson
Baxter

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.