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Generated: October 21, 2018

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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 two NDAs. It is available from one supplier. There are eleven 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:7
Generic Entry Opportunity Date for 205718
Generic Entry Date for 205718*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*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: 205718
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718 NDA Helsinn Therapeutics (U.S.), Inc. 69639-101 69639-101-01 1 BLISTER PACK in 1 CARTON (69639-101-01) > 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

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:➤ Sign UpPatent Expiration:Feb 22, 2020Product Flag?Substance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Nov 18, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY

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Harvard Business School
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US Army
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Queensland Health
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QuintilesIMS
Argus Health

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