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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Citi
Covington
QuintilesIMS
Baxter
McKesson
Chubb
US Army
Harvard Business School

Generated: April 19, 2018

DrugPatentWatch Database Preview

FOSAMAX PLUS D Drug Profile

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When do Fosamax Plus D patents expire, and what generic 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.

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 FOSAMAX PLUS D
Drug patent expirations by year for FOSAMAX PLUS D
Pharmacology for FOSAMAX PLUS D

US Patents and Regulatory Information 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;ORAL 021762-001 Apr 7, 2005 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 FOSAMAX PLUS D

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

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Paragraph IV (Patent) Challenges for FOSAMAX PLUS D
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe 2007-11-20

Non-Orange Book US Patents for 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
6,333,316 Method for inhibiting bone resorption ➤ Try a Free Trial
6,432,932 Method for inhibiting bone resorption ➤ Try a Free Trial
6,465,443 Method for inhibiting bone resorption ➤ Try a Free Trial
6,015,801 Method for inhibiting bone resorption ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for FOSAMAX PLUS D

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904/01 Switzerland ➤ Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
2006 00005 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
364 Luxembourg ➤ Try a Free Trial 91364, EXPIRES: 20200826
00292 Netherlands ➤ Try a Free Trial PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Moodys
Johnson and Johnson
UBS
Deloitte
Farmers Insurance
US Department of Justice
Covington
Express Scripts

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