Details for New Drug Application (NDA): 022003

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NDA 022003 describes NOXAFIL, which is a drug marketed by Merck Sharp Dohme and Schering and is included in three NDAs. It is available from one supplier. There are eight 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. One supplier is listed for this compound. Additional details are available on the posaconazole profile page.

Summary for 022003

Tradename:	NOXAFIL
Applicant:	Schering
Ingredient:	posaconazole
Patents:	2
Formulation / Manufacturing:	see details

Generic Entry Opportunity Date for 022003

Generic Entry Date for 022003^: ➤ Sign Up* Constraining patent/regulatory exclusivity: ➤ Sign Up Dosage: SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022003

Suppliers and Packaging for NDA: 022003

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOXAFIL	posaconazole	SUSPENSION;ORAL	022003	NDA	Merck Sharp & Dohme Corp.	0085-1328	0085-1328-01	1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) > 105 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	Sep 15, 2006	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Jul 19, 2019	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF OROPHARYNGEAL CANDIDIASIS
Patent:	➤ Sign Up	Patent Expiration:	Apr 1, 2022	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022003

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	➤ Sign Up	➤ Sign Up
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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