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Last Updated: March 18, 2024

ACTONEL Drug Patent Profile


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When do Actonel patents expire, and when can generic versions of Actonel launch?

Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs.

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

Drug patent expirations by year for ACTONEL
Drug Prices for ACTONEL

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Drug Sales Revenue Trends for ACTONEL

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Recent Clinical Trials for ACTONEL

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SponsorPhase
Dong-A ST Co., Ltd.Phase 4
Wake Forest University Health SciencesPhase 3
Hospital for Special Surgery, New YorkPhase 4

See all ACTONEL clinical trials

Pharmacology for ACTONEL
Drug ClassBisphosphonate
Paragraph IV (Patent) Challenges for ACTONEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 ACTONEL

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 020835-002 Apr 14, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ACTONEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ⤷  Try a Trial ⤷  Try a Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ACTONEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 C01175904/01 Switzerland ⤷  Try a Trial FORMER OWNER: SCHERING CORPORATION, US
1175904 2007C/048 Belgium ⤷  Try a Trial PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
0998292 CA 2006 00005 Denmark ⤷  Try a Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904 PA2007007 Lithuania ⤷  Try a Trial PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.