ALOXI Drug Patent Profile

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When do Aloxi patents expire, and when can generic versions of Aloxi launch?

Aloxi is a drug marketed by Helsinn Hlthcare and is included in two NDAs. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in forty countries.

The generic ingredient in ALOXI is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aloxi

A generic version of ALOXI was approved as palonosetron hydrochloride by SANDOZ on October 13^th, 2015.

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Summary for ALOXI

International Patents:	53
US Patents:	13
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Patent Applications:	3,953
Drug Prices:	Drug price information for ALOXI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALOXI
What excipients (inactive ingredients) are in ALOXI?	ALOXI excipients list
DailyMed Link:	ALOXI at DailyMed

Drug patent expirations by year for ALOXI

Paragraph IV (Patent) Challenges for ALOXI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALOXI	Injection	palonosetron hydrochloride	0.05 mg/mL, 1.5 mL and 5 mL vials	021372	3	2011-05-27

US Patents and Regulatory Information for ALOXI

ALOXI is protected by seven US patents.

Patents protecting ALOXI

Liquid pharmaceutical formulations of palonosetron
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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	ALOXI	palonosetron hydrochloride	CAPSULE;ORAL	022233-001	Aug 22, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ALOXI

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003	⤷ Sign Up	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	CAPSULE;ORAL	022233-001	Aug 22, 2008	⤷ Sign Up	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003	⤷ Sign Up	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003	⤷ Sign Up	⤷ Sign Up
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ALOXI

See the table below for patents covering ALOXI around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2006516583		⤷ Sign Up
South Korea	101113084		⤷ Sign Up
Georgia, Republic of	P20084445	LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON	⤷ Sign Up
Ukraine	90449	ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ПАЛОНОСЕТРОНА;РІДКІ ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ ПАЛОНОСЕТРОНУ (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)	⤷ Sign Up
Denmark	0430190		⤷ Sign Up
Norway	905120		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ALOXI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	C02785706/01	Switzerland	⤷ Sign Up	PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
0430190	SPC/GB05/032	United Kingdom	⤷ Sign Up	PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
2785706	2020C/516	Belgium	⤷ Sign Up	PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0430190	C00430190/01	Switzerland	⤷ Sign Up	FORMER REPRESENTATIVE: BOHEST AG, CH
0430190	91162	Luxembourg	⤷ Sign Up	91162, EXPIRES: 20151127
2785706	122020000046	Germany	⤷ Sign Up	PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for ALOXI

Paragraph IV (Patent) Challenges for ALOXI

Patents protecting ALOXI

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