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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210493

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NDA 210493 describes AKYNZEO, which is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from one supplier. There are thirteen 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 210493
Generic Entry Opportunity Date for 210493
Generic Entry Date for 210493*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS

*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.

Pharmacology for NDA: 210493
Suppliers and Packaging for NDA: 210493
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride POWDER;INTRAVENOUS 210493 NDA Helsinn Therapeutics (U.S.), Inc. 69639-102 69639-102-01 1 VIAL in 1 CARTON (69639-102-01) > 1 INJECTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 235MG BASE;EQ 0.25MG BASE
Approval Date:Apr 19, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 19, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:May 23, 2032Product 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 HIGHLY EMETOGENIC CANCER CHEMOTHERAPY
Patent:  Start TrialPatent Expiration:May 23, 2032Product Flag?YSubstance Flag?YDelist Request?

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