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Serving leading biopharmaceutical companies globally:

Queensland Health
Colorcon
Moodys
Dow
Argus Health
Healthtrust
Chubb
Merck
US Army
Johnson and Johnson

Generated: December 13, 2017

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 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 are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the netupitant; palonosetron hydrochloride profile page.

Summary for 205718

Tradename:1
Applicant:1
Ingredient:1
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 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 Helsinn Therapeutics (U.S.), Inc. 69639-101 69639-101-04 2 BLISTER PACK in 1 CARTON (69639-101-04) > 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
Regulatory Exclusivity Expiration:Oct 10, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Feb 22, 2020Product Flag?Substance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Nov 18, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING

Expired Orange Book Patents for NDA: 205718

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Helsinn HlthcareAKYNZEOnetupitant; palonosetron hydrochlorideCAPSULE;ORAL205718-001Oct 10, 2014► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Moodys
Teva
QuintilesIMS
Fuji
Chubb
Novartis
Medtronic
Fish and Richardson
Queensland Health
Daiichi Sankyo

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