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Generated: December 11, 2017

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ACTONEL Drug Profile

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When do Actonel patents expire, 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 ninety-seven patent family members in forty-nine countries and nine supplementary protection certificates in five countries.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and seventy 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

Pharmacology for ACTONEL

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
ApilACTONELrisedronate sodiumTABLET;ORAL020835-002Apr 14, 2000ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-004Apr 16, 2007DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Warner ChilcottACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate; risedronate sodiumTABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-001Mar 27, 1998ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: ACTONEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ApilACTONELrisedronate sodiumTABLET;ORAL020835-005Apr 22, 2008► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-004Apr 16, 2007► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-002Apr 14, 2000► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-001Mar 27, 1998► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-001Mar 27, 1998► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-004Apr 16, 2007► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-002Apr 14, 2000► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ACTONEL

Drugname Dosage Strength RLD Submissiondate
risedronate sodiumTablets150 mgActonel8/12/2008
risedronate sodium with calcium carbonateTablets35 mg; 500 mgActonel with Calcium12/18/2007
risedronate sodiumTablets75 mgActonel9/10/2007
risedronate sodiumTablets5 mg, 30 mg and 35 mgActonel4/23/2004

Non-Orange Book Patents for Tradename: ACTONEL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety► Subscribe
6,225,294 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
7,410,957Method of treatment using bisphosphonic acid► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ACTONEL

Country Document Number Estimated Expiration
Australia7446098► Subscribe
New Zealand503946► Subscribe
China1166365► Subscribe
Malaysia140080► Subscribe
South Korea20120065435► Subscribe
Guatemala200300107► Subscribe
South Korea100400053► Subscribe
Argentina027158► Subscribe
South Korea100642961► Subscribe
South Korea20060058151► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ACTONEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006 00005Denmark► Subscribe
364Luxembourg► Subscribe91364, EXPIRES: 20200826
2007007Lithuania► SubscribePRODUCT 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
222Luxembourg► Subscribe91222, EXPIRES: 20200824
2007 00045Denmark► Subscribe
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
2006002Lithuania► SubscribePRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
2006002,C0998292Lithuania► SubscribePRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
00292Netherlands► SubscribePRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
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Serving leading biopharmaceutical companies globally:

Accenture
Julphar
US Army
Cipla
Fuji
Johnson and Johnson
Farmers Insurance
AstraZeneca
UBS
Healthtrust

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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