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FOSAMAX Drug Profile

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Fosamax is a drug marketed by Merck And Co Inc and Merck and is included in three NDAs. It is available from two suppliers. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-five patent family members in forty countries.

The generic ingredient in FOSAMAX is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

Summary for Tradename: FOSAMAX

Patents:3
Applicants:2
NDAs:3
Suppliers / Packagers: see list2

Pharmacology for Tradename: FOSAMAX

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: FOSAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-003Apr 25, 1997DISCNNo<disabled><disabled>
Merck
FOSAMAX
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 2003RXYes6,015,801*PED<disabled>Y<disabled>
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-002Sep 29, 1995DISCNNo<disabled><disabled>
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Expired Patents for Tradename: FOSAMAX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-004Oct 20, 20006,008,207*PED<disabled>
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-001Sep 29, 19956,090,410*PED<disabled>
Merck
FOSAMAX
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 20035,462,932*PED<disabled>
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Paragraph IV activity for: FOSAMAX

Drugname Dosage Strength RLD Submissiondate
alendronate sodium and cholecalciferolTablets70 mg/2800 IU and 70 mg/5600 IUFosamax Plus D11/20/2007
alendronate sodiumOral Solution70 mg/75 mLFosamax9/7/2007

Non-Orange Book Patents for Tradename: FOSAMAX

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
6,544,967 Method for inhibiting bone resorption<disabled in preview>
6,333,316 Method for inhibiting bone resorption<disabled in preview>
6,465,443 Method for inhibiting bone resorption<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: FOSAMAX

Country Document Number Estimated Expiration
Germany69837450<disabled in preview>
Canada2349733<disabled in preview>
China1602879<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: FOSAMAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006002,C0998292Lithuania<disabled>PRODUCT 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
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
1175904/01Switzerland<disabled>FORMER OWNER: SCHERING CORPORATION, US
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