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Serving 500+ biopharmaceutical companies globally:

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Generated: June 27, 2017

DrugPatentWatch Database Preview

FOSAMAX Drug Profile

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Which patents cover Fosamax, and when can generic versions of Fosamax launch?

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

This drug has eighty-six 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
Bulk Api Vendors: see list115
Clinical Trials: see list50
Patent Applications: see list4,882
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:FOSAMAX at DailyMed

Pharmacology for Tradename: FOSAMAX

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-003Apr 25, 1997DISCNYesNo► Subscribe► Subscribe
Merck
FOSAMAX
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 2003DISCNNoNo6,015,801*PED► SubscribeY► Subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-002Sep 29, 1995DISCNYesNo► Subscribe► Subscribe
Merck
FOSAMAX
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 2003DISCNNoNo6,225,294*PED► SubscribeY► Subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-001Sep 29, 1995DISCNYesNo► Subscribe► Subscribe
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Expired Patents for Tradename: FOSAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-001Sep 29, 19956,090,410*PED► Subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-001Sep 29, 19956,194,004*PED► Subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-002Sep 29, 19955,358,941*PED► Subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-003Apr 25, 19975,804,570► Subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-001Sep 29, 19955,804,570► Subscribe
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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► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
6,465,443 Method for inhibiting bone resorption► Subscribe
6,432,932 Method for inhibiting bone resorption► 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: FOSAMAX

Country Document Number Estimated Expiration
Austria357921► Subscribe
Slovakia932000► Subscribe
Netherlands300223► Subscribe
Denmark0998292► Subscribe
Japan3479780► 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: FOSAMAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
2006 00005Denmark► Subscribe
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Queensland Health
Fuji
Colorcon
Accenture
Citi
Novartis
UBS
Deloitte

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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