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Last Updated: November 30, 2021

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, 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. Eight 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 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
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:May 31, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Free Forever TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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