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Last Updated: February 9, 2023

Details for New Drug Application (NDA): 205596


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NDA 205596 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 seven 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. Seventeen suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 205596
Tradename:NOXAFIL
Applicant:Merck Sharp Dohme
Ingredient:posaconazole
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 205596
Suppliers and Packaging for NDA: 205596
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596 NDA Merck Sharp & Dohme LLC 0085-4331 0085-4331-01 1 VIAL, GLASS in 1 CARTON (0085-4331-01) / 16.7 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength300MG/16.7ML (18MG/ML)
Approval Date:Mar 13, 2014TE:APRLD: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 205596

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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