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Helsinn Hlthcare Company Profile

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What is the competitive landscape for HELSINN HLTHCARE, and when can generic versions of HELSINN HLTHCARE drugs launch?

HELSINN HLTHCARE has four approved drugs.

There are twenty-four US patents protecting HELSINN HLTHCARE drugs.

There are two hundred and thirty-five patent family members on HELSINN HLTHCARE drugs in sixty-seven countries and fourteen supplementary protection certificates in ten countries.

Summary for Helsinn Hlthcare

International Patents:	235
US Patents:	24
Tradenames:	2
Ingredients:	3
NDAs:	4

Drugs and US Patents for Helsinn Hlthcare

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	021372-002	Feb 29, 2008	AP	RX	Yes	Yes	7,960,424*PED				Y
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		RX	Yes	Yes
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003	AP	RX	Yes	Yes	7,960,424*PED				Y

Expired US Patents for Helsinn Hlthcare

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	CAPSULE;ORAL	022233-001	Aug 22, 2008	5,202,333
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014	5,202,333
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008	5,202,333*PED

Non-Orange Book US Patents for Helsinn Hlthcare

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,479,483	4-phenyl-pyridine derivatives
9,308,266	Liquid pharmaceutical formulations of palonosetron

International Patents for Helsinn Hlthcare Drugs

Country	Document Number	Estimated Expiration
Italy	MI20000328
Brazil	112014012878
European Patent Office	2727590

Supplementary Protection Certificates for Helsinn Hlthcare Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
15/030	Ireland		PRODUCT NAME: NETUPITANT OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1001 20150527
00758	Netherlands		PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2015036	Lithuania		PRODUCT NAME: NETUPITANTUM; REGISTRATION NO/DATE: EU/1/15/1001 20150527

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Helsinn Hlthcare