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 two 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:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206426

Generic Entry Date for 206426^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 10,391,075 Dosage: SOLUTION;INTRAVENOUS

^*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	BioCryst Pharmaceuticals, Inc.	72769-181	72769-181-03	3 VIAL, GLASS in 1 CARTON (72769-181-03) / 20 mL in 1 VIAL, GLASS (72769-181-01)

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
Patent:	10,391,075	Patent Expiration:	Feb 12, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 2 YEARS AND OLDER
Patent:	10,391,075	Patent Expiration:	Feb 12, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 6 MONTHS AND OLDER
Patent:	8,778,997	Patent Expiration:	May 7, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN ADULTS

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	6,562,861	⤷ Subscribe
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014	6,503,745	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Summary for 206426

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206426

Suppliers and Packaging for NDA: 206426

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206426