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Generated: May 25, 2018

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 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-type	Diphosphonates

Medical Subject Heading (MeSH) Categories for 020560

Bone Density Conservation Agents

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:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Sep 29, 1995	TE:		RLD:	Yes

Profile for product number 002

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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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

Profile for product number 003

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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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

Expired US Patents for NDA 020560

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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

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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.