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Details for New Drug Application (NDA): 205718

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NDA 205718 describes AKYNZEO, which is a drug marketed by Helsinn Hlthcare and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the AKYNZEO profile page.

The generic ingredient in AKYNZEO is netupitant; palonosetron hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the netupitant; palonosetron hydrochloride profile page.

Suppliers and Packaging for NDA: 205718

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKYNZEO
netupitant; palonosetron hydrochloride
CAPSULE;ORAL 205718 NDA Eisai Inc. 62856-796 62856-796-01 1 BLISTER PACK in 1 CARTON (62856-796-01) > 1 CAPSULE in 1 BLISTER PACK
AKYNZEO
netupitant; palonosetron hydrochloride
CAPSULE;ORAL 205718 NDA Eisai Inc. 62856-796 62856-796-04 2 BLISTER PACK in 1 CARTON (62856-796-04) > 2 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG;EQ 0.5MG BASE
Approval Date:Oct 10, 2014TE:RLD:Yes
Patent:6,297,375Patent Expiration:Feb 22, 2020Product Flag?Substance Flag?YDelist Request?
Patent:8,951,969Patent Expiration:Nov 18, 2030Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Oct 10, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired Orange Book Patents for NDA: 205718

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Helsinn Hlthcare
AKYNZEO
netupitant; palonosetron hydrochloride
CAPSULE;ORAL205718-001Oct 10, 20145,202,333► subscribe
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