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Serving leading biopharmaceutical companies globally:

Covington
Moodys
Merck
AstraZeneca
Harvard Business School
Chinese Patent Office
McKesson
Mallinckrodt
Teva
Federal Trade Commission

Generated: December 10, 2017

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 one supplier. 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 fourteen 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 205596

Tradename:1
Applicant:1
Ingredient:1
Patents:5
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 205596

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 205596

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOXAFIL posaconazole SOLUTION;IV (INFUSION) 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength300MG/16.7ML (18MG/ML)
Approval Date:Mar 13, 2014TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
Patent:► SubscribePatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jul 4, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS

Expired Orange Book Patents for NDA: 205596

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeNOXAFILposaconazoleSOLUTION;IV (INFUSION)205596-001Mar 13, 2014► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fuji
Daiichi Sankyo
Citi
US Department of Justice
Colorcon
Teva
Medtronic
Cipla
Julphar
Queensland Health

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