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Last Updated: January 18, 2020

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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. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

US ANDA Litigation and Generic Entry Outlook for Fosamax Plus D

  Start Trial

Fosamax Plus D was eligible for patent challenges on December 31st, 1968.

There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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

See drug prices for FOSAMAX PLUS D

Recent Clinical Trials for FOSAMAX PLUS D

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Massachusetts General HospitalPhase 4
Tuen Mun HospitalPhase 4
Wisconsin Partnership ProgramPhase 1

See all FOSAMAX PLUS D clinical trials

Recent Litigation for FOSAMAX PLUS D

Identify potential future generic entrants

District Court Litigation
Case NameDate
Warner Chilcott Company v. Teva Pharmaceuticals USA Inc.2008-09-26
Procter & Gamble Company v. Teva Pharmaceuticals USA Inc.2008-02-01
AstraZeneca Pharmaceuticals LP v. Apotex Inc.2007-12-11

See all FOSAMAX PLUS D litigation

Pharmacology for FOSAMAX PLUS D
Paragraph IV (Patent) Challenges for FOSAMAX PLUS D
Tradename Dosage Ingredient NDA Submissiondate
FOSAMAX PLUS D TABLET;ORAL alendronate sodium; cholecalciferol 021762 2007-11-20

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

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

Supplementary Protection Certificates for FOSAMAX PLUS D

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0998292 91222 Luxembourg   Start Trial 91222, EXPIRES: 20200824
0998292 PA2006002,C0998292 Lithuania   Start Trial 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
0998292 CA 2006 00005 Denmark   Start Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
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Merck
McKinsey
Mallinckrodt
Harvard Business School

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