.

Deeper Knowledge, Faster

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Argus Health
Express Scripts
Cipla
Novartis
McKinsey
Farmers Insurance
Fish and Richardson
Daiichi Sankyo
Colorcon
Chubb

Generated: September 24, 2017

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 Co Inc and Merck 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 NDA: 020560

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020560

Ingredient-typeDiphosphonates

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)
FOSAMAX
alendronate sodium
TABLET;ORAL 020560 NDA Physicians Total Care, Inc. 54868-3857 54868-3857-0 30 TABLET, COATED in 1 BOTTLE (54868-3857-0)

Summary 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10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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 Orange Book Patents for NDA: 020560



Complete Access Available with Subscription
« Back to Dashboard

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

Serving 500+ biopharmaceutical companies globally:

Citi
Baxter
Argus Health
Daiichi Sankyo
Accenture
Covington
Novartis
Colorcon
Fuji
McKesson

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot