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Serving leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
US Army
Baxter
Argus Health
Teva
Mallinckrodt
Colorcon
Merck
Cipla

Generated: December 11, 2017

DrugPatentWatch Database Preview

Alendronate sodium; cholecalciferol - Generic Drug Details

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What are the generic drug sources for alendronate sodium; cholecalciferol and what is the scope of alendronate sodium; cholecalciferol patent protection?

Alendronate sodium; cholecalciferol
is the generic ingredient in one branded drug marketed by Merck and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium; cholecalciferol has ninety-one patent family members in forty countries and nine supplementary protection certificates in five countries.

There are twenty-five drug master file entries for alendronate sodium; cholecalciferol. Two suppliers are listed for this compound.

Summary for alendronate sodium; cholecalciferol

Pharmacology for alendronate sodium; cholecalciferol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-001Apr 7, 2005RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-002Apr 26, 2007RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: alendronate sodium; cholecalciferol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-002Apr 26, 2007► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-001Apr 7, 2005► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-002Apr 26, 2007► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-002Apr 26, 2007► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-001Apr 7, 2005► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-002Apr 26, 2007► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-001Apr 7, 2005► Subscribe► Subscribe
MerckFOSAMAX PLUS Dalendronate sodium; cholecalciferolTABLET;ORAL021762-001Apr 7, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: alendronate sodium; cholecalciferol

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
6,544,967 Method for inhibiting bone resorption► Subscribe
6,432,932 Method for inhibiting bone resorption► Subscribe
6,465,443 Method for inhibiting bone resorption► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
6,225,294 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 Ingredient: alendronate sodium; cholecalciferol

Country Document Number Estimated Expiration
China1166365► Subscribe
Denmark1175904► Subscribe
Israel153109► Subscribe
Germany69803291► Subscribe
Luxembourg91364► Subscribe
European Patent Office1175904► Subscribe
Ukraine67748► Subscribe
Japan2002502433► Subscribe
Canada2349733► Subscribe
South Korea20030097610► 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: ALENDRONATE SODIUM; CHOLECALCIFEROL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006 00005Denmark► Subscribe
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
222Luxembourg► Subscribe91222, EXPIRES: 20200824
2007 00045Denmark► Subscribe
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Fuji
Moodys
US Department of Justice
Teva
Federal Trade Commission
QuintilesIMS
Argus Health
AstraZeneca
Mallinckrodt

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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