Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
McKesson
Queensland Health
Colorcon
Medtronic
Covington
Argus Health
UBS

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205718

« Back to Dashboard

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
Tradename:AKYNZEO
Applicant:Helsinn Hlthcare
Ingredient:netupitant; palonosetron hydrochloride
Patents:5
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?
Patented Use:PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKesson
QuintilesIMS
Farmers Insurance
Citi
Chubb
Medtronic
Boehringer Ingelheim
Argus Health
Teva

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.