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

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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020560

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NDA 020560 describes FOSAMAX, which is a drug marketed by Merck and Merck And Co Inc and is included in three NDAs. It is available from one supplier. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FOSAMAX profile page.

The generic ingredient in FOSAMAX 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.
Summary for 020560
Tradename:FOSAMAX
Applicant:Merck And Co Inc
Ingredient:alendronate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020560
Medical Subject Heading (MeSH) Categories for 020560
Suppliers and Packaging for NDA: 020560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSAMAX alendronate sodium TABLET;ORAL 020560 NDA Merck Sharp & Dohme Corp. 0006-0031 0006-0031-44 4 TABLET in 1 BLISTER PACK (0006-0031-44)
Paragraph IV (Patent) Challenges for 020560
Tradename Dosage Ingredient NDA Submissiondate
FOSAMAX TABLET;ORAL alendronate sodium 020560

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 29, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 29, 1995TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 25, 1997TE:RLD:Yes

Expired US Patents for NDA 020560

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000   Start Trial   Start Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000   Start Trial   Start Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995   Start Trial   Start Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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