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ACTONEL Drug Profile

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

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

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and fifty-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 list3

Pharmacology for Tradename: ACTONEL

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: ACTONEL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 2000RXNo6,165,513*PED<disabled>Y<disabled>
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002RXYes5,994,329*PED<disabled>Y<disabled>
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002RXYes6,432,932*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ACTONEL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-004Apr 16, 20075,583,122*PED<disabled>
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 19985,583,122*PED<disabled>
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 20085,583,122*PED<disabled>
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Paragraph IV activity 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
6,225,294 Method for inhibiting bone resorption<disabled in preview>
6,544,967 Method for inhibiting bone resorption<disabled in preview>
7,410,957Method of treatment using bisphosphonic acid<disabled in preview>
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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
Japan2013166773<disabled in preview>
Australia8493698<disabled in preview>
Japan2013067642<disabled in preview>
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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
2007007Lithuania<disabled>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
00292Netherlands<disabled>PRODUCT 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
364Luxembourg<disabled>91364, EXPIRES: 20200826
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