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Last Updated: November 22, 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
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132-003 Oct 5, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Orbion Pharms RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 205280-001 May 13, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477-005 Jun 10, 2014 DISCN 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 020835-001 Mar 27, 1998 ⤷  Sign Up ⤷  Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Sign Up ⤷  Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Sign Up ⤷  Sign Up
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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