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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Argus Health

Generated: May 23, 2018

DrugPatentWatch Database Preview

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 two NDAs. 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 fosnetupitant chloride hydrochloride; palonosetron hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fosnetupitant chloride hydrochloride; palonosetron hydrochloride profile page.
Summary for 205718
Applicant:Helsinn Hlthcare
Ingredient:netupitant; palonosetron hydrochloride
Formulation / Manufacturing:see details
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 N 62856-796-01
AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718 NDA Helsinn Therapeutics (U.S.), Inc. 69639-101 N 69639-101-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG;EQ 0.5MG BASE
Approval Date:Oct 10, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 10, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Feb 22, 2020Product Flag?Substance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Nov 18, 2030Product Flag?Substance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Argus Health

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