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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205596

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NDA 205596 describes NOXAFIL, which is a drug marketed by Merck Sharp Dohme and Schering and is included in three NDAs. It is available from two 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. Four suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 205596
Applicant:Merck Sharp Dohme
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 Corp. 0085-4331 0085-4331-01 1 VIAL, GLASS in 1 CARTON (0085-4331-01) > 16.7 mL in 1 VIAL, GLASS
Paragraph IV (Patent) Challenges for 205596
Tradename Dosage Ingredient NDA Submissiondate
NOXAFIL SOLUTION;INTRAVENOUS posaconazole 205596 2015-11-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength300MG/16.7ML (18MG/ML)
Approval Date:Mar 13, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 4, 2031Product Flag?YSubstance Flag?Delist Request?

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