Details for New Drug Application (NDA): 205053

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NDA 205053 describes NOXAFIL, which is a drug marketed by Merck Sharp Dohme, Schering, and Msd Merck Co, and is included in four NDAs. It is available from three suppliers. There are six patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NOXAFIL profile page.

The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

Summary for 205053

Tradename:	NOXAFIL
Applicant:	Merck Sharp Dohme
Ingredient:	posaconazole
Patents:	0

Pharmacology for NDA: 205053

Suppliers and Packaging for NDA: 205053

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053	NDA	Merck Sharp & Dohme LLC	0085-4324	0085-4324-02	60 TABLET, COATED in 1 BOTTLE (0085-4324-02)
NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053	NDA AUTHORIZED GENERIC	ENDO USA, Inc.	0254-2045	0254-2045-02	60 TABLET, COATED in 1 BOTTLE (0254-2045-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 25, 2013	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 17, 2028
Regulatory Exclusivity Use:	FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
Regulatory Exclusivity Expiration:	Jun 17, 2024
Regulatory Exclusivity Use:	FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER
Regulatory Exclusivity Expiration:	May 31, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 205053

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013	5,661,151	⤷ Subscribe
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013	5,703,079	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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