Details for New Drug Application (NDA): 206426

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NDA 206426 describes RAPIVAB, which is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the RAPIVAB profile page.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the peramivir profile page.

Summary for 206426

Tradename:	RAPIVAB
Applicant:	Biocryst
Ingredient:	peramivir
Patents:	3

Generic Entry Opportunity Date for 206426

Generic Entry Date for 206426^: ➤ Try a Free Trial* Constraining patent/regulatory exclusivity: NEW PATIENT POPULATION Dosage: SOLUTION;IV (INFUSION)

^*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.

Suppliers and Packaging for NDA: 206426

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426	NDA	bioCSL Inc.	61364-181	61364-181-03	3 VIAL, GLASS in 1 CARTON (61364-181-03) > 20 mL in 1 VIAL, GLASS (61364-181-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MG/20ML (10MG/ML)
Approval Date:	Dec 19, 2014	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 19, 2019
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Sep 20, 2020
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	➤ Try a Free Trial	Patent Expiration:	Nov 5, 2019	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 206426

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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