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Generated: April 29, 2017

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ACTONEL Drug Profile

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What is the patent landscape for Actonel, and what generic alternatives are available?

Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and eighty-three patent family members in forty-nine countries.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and sixty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for Tradename: ACTONEL

Patents:7
Applicants:2
NDAs:2
Suppliers / Packagers: see list4
Bulk Api Vendors: see list101
Clinical Trials: see list16
Patent Applications: see list3,311
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ACTONEL at DailyMed

Pharmacology for Tradename: ACTONEL

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
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;ORAL020835-002Apr 14, 2000ABRXYesNo6,165,513*PED► SubscribeY► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002ABRXYesYes6,465,443*PED► SubscribeY► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002ABRXYesYes6,015,801*PED► SubscribeY► Subscribe
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo5,994,329*PED► SubscribeY► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-004Apr 16, 2007DISCNYesNo6,165,513*PED► SubscribeY► Subscribe
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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 verifification 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.

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