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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Accenture
Argus Health
Merck
Covington
Chubb
Fuji
Baxter
Johnson and Johnson
Fish and Richardson

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021575

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NDA 021575 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: 021575

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrengthEQ 70MG BASE/75ML
Approval Date:Sep 17, 2003TE:RLD:No
Patent:5,994,329*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,015,801*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,225,294*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021575

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
FOSAMAX
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 20034,621,077*PED► Subscribe
Merck
FOSAMAX
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 20035,462,932*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Covington
Dow
Cerilliant
McKesson
UBS
QuintilesIMS
Julphar
Novartis
Queensland Health
Cantor Fitzgerald

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.

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