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Serving leading biopharmaceutical companies globally:

AstraZeneca
Cerilliant
US Department of Justice
Teva
Farmers Insurance
Julphar
Colorcon
Daiichi Sankyo
Mallinckrodt
Cantor Fitzgerald

Generated: November 19, 2017

DrugPatentWatch Database Preview

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 ninety-one patent family members in forty countries and nine supplementary protection certificates in five 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.

Pharmacology for 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, 2005RXYesNo► Subscribe► SubscribeY► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 2007RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
6,015,801 Method for inhibiting bone resorption► Subscribe
6,432,932 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
6,225,294 Method for inhibiting bone resorption► Subscribe
6,465,443 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
Australia8493698► Subscribe
World Intellectual Property Organization (WIPO)0115703► Subscribe
Australia6406900► Subscribe
Germany122007000063► Subscribe
Spain2253136► Subscribe
Yugoslavia1800► Subscribe
China1602879► Subscribe
Turkey200805763► Subscribe
China1265035► Subscribe
Hungary0004653► 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
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
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
2007 00045Denmark► Subscribe
00292Netherlands► SubscribePRODUCT 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► Subscribe91364, EXPIRES: 20200826
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
222Luxembourg► Subscribe91222, EXPIRES: 20200824
2006 00005Denmark► Subscribe
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
Queensland Health
Harvard Business School
Cantor Fitzgerald
Merck
Novartis
Baxter
Cipla
Covington

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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