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Last Updated: August 8, 2020

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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 Orchid Hlthcare, 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 forty-nine patent family members in thirty-six countries.

There are nineteen 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
TakedaN/A
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 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
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apotex Inc RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090877-002 Jun 10, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090886-005 Jun 10, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes   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

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   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
McKesson
Express Scripts
Johnson and Johnson
Baxter

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