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Last Updated: April 19, 2024

Fosnetupitant chloride hydrochloride; palonosetron hydrochloride - Generic Drug Details

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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-six patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for fosnetupitant chloride hydrochloride; palonosetron hydrochloride

International Patents:	176
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

Generic Entry Date for fosnetupitant chloride hydrochloride; palonosetron hydrochloride^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Anatomical Therapeutic Chemical (ATC) Classes for fosnetupitant chloride hydrochloride; palonosetron hydrochloride

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

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

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Glossary

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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	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for fosnetupitant chloride hydrochloride; palonosetron hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Slovenia	3435980		⤷ Try a Trial
China	106518924	用于治疗 NK‑1 受体相关疾病的取代的 4‑苯基吡啶 (Substituted 4 - phenyl - pyridines for the treatment of NK-1 receptor related diseases)	⤷ Try a Trial
Nicaragua	201400043	4 - FENIL - PIRIDINAS SUSTITUIDAS PARA EL TRATAMIENTO DE ENFERMEDADES RELACIONADAS CON EL RECEPTOR DE NK1	⤷ Try a Trial
Moldova, Republic of	3435980		⤷ Try a Trial
South Korea	20190015276	포스네투피탄트의 생리학적으로 균형잡힌 주사가능 제제	⤷ Try a Trial
Malaysia	194081	PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT	⤷ Try a Trial
Tunisia	2012000170	COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fosnetupitant chloride hydrochloride; palonosetron hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	C02785706/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
2785706	2020C/516	Belgium	⤷ Try a Trial	PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
2785706	2020030	Norway	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT OG FARMASOEYTISK AKSEPTABLE SALTER OG SOLVATER DERAV SPESIELT FOSNETUPITANT KLORID HYDROKLORID; REG. NO/DATE: EU/1/15/1001 20200318
2785706	301047	Netherlands	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FOSNETUPITANTCHLORIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1001 20200318
2785706	PA2020510	Lithuania	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20200316
2785706	2090015-5	Sweden	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT; REG. NO/DATE: EU/1/15/1001 20200317
2785706	LUC00158	Luxembourg	⤷ Try a Trial	PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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