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Generated: July 22, 2017

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FOSAMAX PLUS D Drug Profile

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What is the patent landscape for Fosamax Plus D, and what generic Fosamax Plus D alternatives are available?

Fosamax Plus D is a drug marketed by Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in FOSAMAX PLUS D 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 PLUS D

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Clinical Trials: see list9,561
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:FOSAMAX PLUS D at DailyMed

Pharmacology for Tradename: FOSAMAX PLUS D

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 2005RXYesNo5,994,329*PED► SubscribeY► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 2007RXYesYes► Subscribe► Subscribe
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Expired Patents for Tradename: FOSAMAX PLUS D

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 20074,621,077*PED► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 20075,358,941*PED► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 20054,621,077*PED► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 20075,681,590*PED► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 20055,681,590*PED► Subscribe
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Paragraph IV activity for: FOSAMAX PLUS D

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

Non-Orange Book Patents for Tradename: FOSAMAX PLUS D

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
6,465,443 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
6,015,801 Method for inhibiting bone resorption► Subscribe
6,333,316 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 PLUS D

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9904773► Subscribe
Australia6406900► Subscribe
European Patent Office1175903► Subscribe
Malaysia118194► Subscribe
European Patent Office1132088► 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 PLUS D

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
222Luxembourg► Subscribe91222, EXPIRES: 20200824
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
2007 00045Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
AstraZeneca
Fuji
Daiichi Sankyo
Baxter
US Army
QuintilesIMS
Cipla
McKesson
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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