NETUPITANT; PALONOSETRON HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for netupitant; palonosetron hydrochloride and what is the scope of freedom to operate?

Netupitant; palonosetron hydrochloride is the generic ingredient in one branded drug marketed by Helsinn Hlthcare and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Netupitant; palonosetron hydrochloride has seventy-six patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for NETUPITANT; PALONOSETRON HYDROCHLORIDE

International Patents:	76
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	16
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NETUPITANT; PALONOSETRON HYDROCHLORIDE
DailyMed Link:	NETUPITANT; PALONOSETRON HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NETUPITANT; PALONOSETRON HYDROCHLORIDE

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.

Recent Clinical Trials for NETUPITANT; PALONOSETRON HYDROCHLORIDE

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

Sponsor	Phase
Helsinn Healthcare SA	Phase 4
Instituto Brasileiro de Controle do Cancer	Phase 2
Albert Einstein College of Medicine, Inc.	Phase 2

See all NETUPITANT; PALONOSETRON HYDROCHLORIDE clinical trials

Pharmacology for NETUPITANT; PALONOSETRON HYDROCHLORIDE

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

US Patents and Regulatory Information for NETUPITANT; PALONOSETRON HYDROCHLORIDE

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
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes			Y	Y
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			Y	Y

Expired US Patents for NETUPITANT; PALONOSETRON HYDROCHLORIDE

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 NETUPITANT; PALONOSETRON HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201290356	КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ТОШНОТЫ И РВОТЫ ЦЕНТРАЛЬНОГО ПРОИСХОЖДЕНИЯ
Brazil	112012011485	"composições e métodos para tratar náusea e vômito centralmente mediados".
Slovenia	2722045
Tunisia	2012000170	COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING
Cuba	24048	COMPOSICIONES PARA TRATAR NÁUSEA Y VÓMITO CENTRALMENTE MEDIADOS

Supplementary Protection Certificates for NETUPITANT; PALONOSETRON HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1035115	C01035115/01	Switzerland		PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: SWISSMEDIC 65499 06.11.2015
1035115	43/2015	Austria		PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2785706	20C1029	France		PRODUCT NAME: FOSNETUPITANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SEL DE CHLORHYDRATE DE CHLORURE DE FOSNETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20200318
2785706	122020000050	Germany		PRODUCT NAME: FOSNETUPITANT; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
2785706	2090015-5	Sweden		PRODUCT NAME: FOSNETUPITANT; REG. NO/DATE: EU/1/15/1001 20200317