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ALOXI Drug Profile

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Aloxi is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting this drug.

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

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

Summary for Tradename: ALOXI

Patents:13
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: ALOXI

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-001Jul 25, 2003RXYes► subscribe► subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
CAPSULE;ORAL022233-001Aug 22, 2008DISCNNo► subscribe► subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-001Jul 25, 2003RXYes7,947,724*PED► subscribeY► subscribe
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Expired Patents for Tradename: ALOXI

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
CAPSULE;ORAL022233-001Aug 22, 20085,202,333► subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-002Feb 29, 20085,202,333*PED► subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-001Jul 25, 20035,202,333*PED► subscribe
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Non-Orange Book Patents for Tradename: ALOXI

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
9,308,266Liquid pharmaceutical formulations of palonosetron► subscribe
9,439,854Liquid pharmaceutical formulations of palonosetron► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ALOXI

Country Document Number Estimated Expiration
Hungary907660► subscribe
Cyprus1108660► subscribe
Brazil1100680► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ALOXI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
745Luxembourg► subscribePRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
C/GB05/032United Kingdom► subscribePRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
0194Netherlands► subscribe300194, 20101127, EXPIRES: 20151126
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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