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AKYNZEO Drug Profile

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When do Akynzeo patents expire, and what generic alternatives are available?

Akynzeo is a drug marketed by Helsinn Hlthcare and is included in two NDAs. There are thirteen patents protecting this drug.

This drug has two hundred and eleven patent family members in sixty-seven countries.

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.

US ANDA Litigation and Generic Entry Outlook for Akynzeo

Akynzeo will be eligible for patent challenges on April 19, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 23, 2032. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AKYNZEO

International Patents:	211
US Patents:	13
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Clinical Trials:	5
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AKYNZEO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AKYNZEO
DailyMed Link:	AKYNZEO at DailyMed

See drug prices for AKYNZEO

Generic Entry Opportunity Date for AKYNZEO

NDA:

205718

Dosage:

CAPSULE;ORAL

NDA:

210493

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.

Recent Clinical Trials for AKYNZEO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
VIFORFRANCE	Phase 4
Christina Ruhlmann	Phase 2/Phase 3
George Clinical Pty Ltd	Phase 3

See all AKYNZEO clinical trials

Recent Litigation for AKYNZEO

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.	2015-12-04
HELSINN HEALTHCARE S.A. v. HOSPIRA, INC.	2015-03-23
Helsinn Healthcare SA v. Cipla Ltd.	2013-04-16

See all AKYNZEO litigation

Pharmacology for AKYNZEO

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist Serotonin-3 Receptor Antagonist
Mechanism of Action	Neurokinin 1 Antagonists Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Breast Cancer Resistance Protein Inhibitors Serotonin 3 Receptor Antagonists

US Patents and Regulatory Information for AKYNZEO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes				Y
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		RX	Yes	Yes				Y
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes			Y	Y

Expired US Patents for AKYNZEO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014

International Patents for AKYNZEO

Country	Patent Number	Estimated Expiration
Peru	20141421
Luxembourg	92745
Japan	3399900
Norway	20000885
Cyprus	1118416

Supplementary Protection Certificates for AKYNZEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1035115	15C0049	France		PRODUCT NAME: NETUPITANT OU L'UN DE SES SELS D'ADDITION D'ACIDES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1001 20150529
1035115	92745	Luxembourg		PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
1035115	2015/030	Ireland		PRODUCT NAME: NETUPITANT OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1001 20150527
1035115	C01035115/01	Switzerland		PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: SWISSMEDIC 65499 06.11.2015
1035115	300758	Netherlands		PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1001 20150527