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Generated: April 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205053

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NDA 205053 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 205053
Applicant:Merck Sharp Dohme
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205053
Generic Entry Date for 205053*:
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: 205053
Suppliers and Packaging for NDA: 205053
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053 NDA Merck Sharp & Dohme Corp. 0085-4324 0085-4324-02 60 TABLET, COATED in 1 BOTTLE (0085-4324-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Nov 25, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?YDelist Request?

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