Helsinn Hlthcare Company Profile

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HELSINN HLTHCARE has five approved drugs.

There are thirty-seven US patents protecting HELSINN HLTHCARE drugs.

There are three hundred and thirty-six patent family members on HELSINN HLTHCARE drugs in fifty-eight countries and twenty-three supplementary protection certificates in fourteen countries.

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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	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No	7,947,724*PED	⤷ 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	8,426,450	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008		DISCN	Yes	No	7,947,724*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No	8,598,219*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No	9,067,896	⤷ 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	11,529,362	⤷ Try a Trial	Y			⤷ Try a Trial
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No	9,457,021*PED	⤷ 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

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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	5,202,333	⤷ Try a Trial
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008	9,125,905	⤷ Try a Trial
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008	5,202,333*PED	⤷ Try a Trial
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	CAPSULE;ORAL	022233-001	Aug 22, 2008	5,202,333	⤷ Try a Trial
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003	5,202,333*PED	⤷ Try a Trial
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014	6,297,375	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	132020000000094	Italy	⤷ Try a Trial	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	2090015-5	Sweden	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT; REG. NO/DATE: EU/1/15/1001 20200317
2785706	PA2020510	Lithuania	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20200316
2785706	C02785706/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
2785706	LUC00158	Luxembourg	⤷ Try a Trial	PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0430190	18/2005	Austria	⤷ Try a Trial	PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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