Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Accenture
Baxter
AstraZeneca
Chubb
Daiichi Sankyo
Harvard Business School
Farmers Insurance

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020560

« Back to Dashboard

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 two suppliers. 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. Two suppliers are 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
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020560
Ingredient-typeDiphosphonates
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 N 0006-0031-44
FOSAMAX alendronate sodium TABLET;ORAL 020560 NDA Physicians Total Care, Inc. 54868-3857 E 54868-3857-0

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10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 020560-005 Oct 20, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Teva
McKinsey
Chinese Patent Office
Mallinckrodt
Cipla
Queensland Health
Boehringer Ingelheim
Chubb

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.