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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cipla
Federal Trade Commission
US Department of Justice
Merck
Dow
Harvard Business School
Johnson and Johnson
Cantor Fitzgerald

Generated: July 17, 2018

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.

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

US Patents and Regulatory Information for alendronate sodium; cholecalciferol

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;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for alendronate sodium; cholecalciferol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Sign Up
6,225,294 Method for inhibiting bone resorption ➤ Sign Up
6,333,316 Method for inhibiting bone resorption ➤ Sign Up
6,432,932 Method for inhibiting bone resorption ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for alendronate sodium; cholecalciferol

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006002 Lithuania ➤ Sign Up PRODUCT 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
364 Luxembourg ➤ Sign Up 91364, EXPIRES: 20200826
2007007 Lithuania ➤ Sign Up PRODUCT 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 00045 Denmark ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Argus Health
Queensland Health
Covington
Fish and Richardson
Dow
US Army
Chinese Patent Office
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.