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ACTONEL WITH CALCIUM (COPACKAGED) Drug Profile

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Actonel With Calcium (copackaged) is a drug marketed by Warner Chilcott and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and nineteen patent family members in forty-four countries.

The generic ingredient in ACTONEL WITH CALCIUM (COPACKAGED) 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 WITH CALCIUM (COPACKAGED)

Patents:5
Applicants:1
NDAs:1
Formulation / Manufacturing:see details

Clinical Trials for: ACTONEL WITH CALCIUM (COPACKAGED)

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,465,443*PED<disabled>Y<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,015,801*PED<disabled>Y<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 2005DISCNNo6,432,932*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 20055,583,122*PED<disabled>
Warner Chilcott
ACTONEL WITH CALCIUM (COPACKAGED)
calcium carbonate; risedronate sodium
TABLET, TABLET;ORAL021823-001Aug 12, 20056,096,342*PED<disabled>
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Non-Orange Book Patents for Tradename: ACTONEL WITH CALCIUM (COPACKAGED)

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>
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety<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 WITH CALCIUM (COPACKAGED)

Country Document Number Estimated Expiration
Germany01201913<disabled in preview>
Serbia49979<disabled in preview>
European Patent Office1175904<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 WITH CALCIUM (COPACKAGED)

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
2008006,C0933372Lithuania<disabled>PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2014 00050Denmark<disabled>PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
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