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Serving leading biopharmaceutical companies globally:

Deloitte
Daiichi Sankyo
McKinsey
Julphar
Citi
Chubb
Dow
Boehringer Ingelheim
Covington
Argus Health

Generated: December 14, 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 Merck And Co Inc and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has ninety-one patent family members in forty countries and nine supplementary protection certificates in five 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.
Drug patent expirations by year for FOSAMAX

Pharmacology for FOSAMAX

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
MerckFOSAMAXalendronate sodiumSOLUTION;ORAL021575-001Sep 17, 2003DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-002Sep 29, 1995DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-003Apr 25, 1997DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-005Oct 20, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
MerckFOSAMAXalendronate sodiumSOLUTION;ORAL021575-001Sep 17, 2003DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
MerckFOSAMAXalendronate sodiumSOLUTION;ORAL021575-001Sep 17, 2003DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-004Oct 20, 2000DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-001Sep 29, 1995DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-002Apr 26, 2007RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-001Apr 7, 2005RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges 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
6,333,316 Method for inhibiting bone resorption► Subscribe
6,544,967 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
Bulgaria104093► Subscribe
New Zealand501807► Subscribe
Israel141218► Subscribe
Canada2349733► Subscribe
Canada2349744► Subscribe
New Zealand508507► Subscribe
Denmark1175904► Subscribe
Japan2002502433► Subscribe
Singapore109478► Subscribe
Bulgaria66282► 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
222Luxembourg► Subscribe91222, EXPIRES: 20200824
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
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
364Luxembourg► Subscribe91364, EXPIRES: 20200826
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
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
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
2006 00005Denmark► Subscribe
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Julphar
Citi
Deloitte
AstraZeneca
Cerilliant
Dow
Moodys
Chubb

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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