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 four 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:	4

Generic Entry Opportunity Date for 206426

Generic Entry Date for 206426^: Start Trial* Constraining patent/regulatory exclusivity: NEW PATIENT POPULATION 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	Seqirus USA 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:	Start Trial	Patent Expiration:	Feb 12, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 2 YEARS AND OLDER

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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