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Generated: April 20, 2019

DrugPatentWatch Database Preview

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
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022003
Generic Entry Date for 022003*:
Constraining patent/regulatory exclusivity:

*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:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Sep 15, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Apr 1, 2022Product Flag?YSubstance Flag?Delist Request?

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