FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE - Generic Drug Details

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

Fosnetupitant chloride hydrochloride; 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.

Fosnetupitant chloride hydrochloride; palonosetron hydrochloride has one hundred and seventy-seven patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

International Patents:	177
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
DailyMed Link:	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE at DailyMed

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

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 FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Paragraph IV (Patent) Challenges for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AKYNZEO	Solution in SDV	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	235 mg/0.25 mg per 20 mL	210493	1	2022-04-19

US Patents and Regulatory Information for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; 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	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes				Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No			Y	Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes			Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes			Y	Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes			Y	Y

International Patents for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201290356	КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ТОШНОТЫ И РВОТЫ ЦЕНТРАЛЬНОГО ПРОИСХОЖДЕНИЯ
Malaysia	159393	COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING
Morocco	35836	4 phényl-pyridines substituées pour le traitement de maladies associées à un récepteur nk-1
Lithuania	3435980
Cyprus	2020017
China	109310627	福奈妥匹坦的生理平衡注射制剂 (Physiologically balanced injectable formulations of fosnetupitant)
Georgia, Republic of	P201706695	SUBSTITUTED 4-PHENYL-PYRIDI-NES FOR THE TREATMENT OF NK-1 RECEPTOR RELATED DISEASES

Supplementary Protection Certificates for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	SPC/GB20/037	United Kingdom		PRODUCT NAME: FOSNETUPITANT; REGISTERED: UK EU/1/15/1001 (NI) 20200318; UK PLGB 12333/0017-0001 20200318
2785706	132020000000094	Italy		PRODUCT NAME: FOSNETUPITANT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL SUO SALE CLORURO CLORIDRATO(AKYNZEO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1001/001-002, 20200316
2785706	PA2020510,C2785706	Lithuania		PRODUCT NAME: FOSNETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20200316
2785706	CA 2020 00028	Denmark		PRODUCT NAME: FOSNETUPITANT OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER HERAF, SAERLLIGT FOSNETUPITANT KLORID HYDROKLORID; REG. NO/DATE: EU/1/15/1001 20200318
2785706	LUC00158	Luxembourg		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
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	C02785706/01	Switzerland		PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022