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Generated: November 18, 2018

DrugPatentWatch Database Preview

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*:
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:RXDosage:SOLUTION;INTRAVENOUSStrength200MG/20ML (10MG/ML)
Approval Date:Dec 19, 2014TE: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:➤ Sign UpPatent Expiration:Nov 5, 2019Product Flag?Substance Flag?YDelist Request?

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