Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Harvard Business School
Dow
Medtronic

Last Updated: October 17, 2019

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

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

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Recent Clinical Trials for FOSAMAX PLUS D

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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

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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

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

Paragraph IV (Patent) Challenges for FOSAMAX PLUS D
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe   Start Trial

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 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
1175904 91364 Luxembourg   Start Trial 91364, EXPIRES: 20200826
1175904 CA 2007 00045 Denmark   Start Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
1175904 C01175904/01 Switzerland   Start Trial FORMER OWNER: SCHERING CORPORATION, US
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
Boehringer Ingelheim
Mallinckrodt
Merck
Dow
McKinsey

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