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Serving leading biopharmaceutical companies globally:

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Healthtrust
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US Department of Justice
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Palonosetron hydrochloride - Generic Drug Details

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What are the generic sources for palonosetron hydrochloride and what is the scope of palonosetron hydrochloride patent protection?

Palonosetron hydrochloride
is the generic ingredient in two branded drugs marketed by Helsinn Hlthcare, Dr Reddys Labs Ltd, Sandoz Inc, and Exela Pharma Science, and is included in six NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Palonosetron hydrochloride has fifty-three patent family members in forty countries.

There are twenty-one drug master file entries for palonosetron hydrochloride. Two suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for palonosetron hydrochloride
Pharmacology for palonosetron hydrochloride
Tentative approvals for PALONOSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ SubscribeEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE;INTRAVENOUS
➤ Subscribe➤ SubscribeEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE;INTRAVENOUS
➤ Subscribe➤ Subscribe0.25MG/5MLINJECTABLE;INJECTION

US Patents and Regulatory Information for palonosetron hydrochloride

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 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride CAPSULE;ORAL 022233-001 Aug 22, 2008 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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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Expired US Patents for palonosetron hydrochloride

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

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Non-Orange Book US Patents for palonosetron hydrochloride

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
9,308,266 Liquid pharmaceutical formulations of palonosetron ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for palonosetron hydrochloride

Supplementary Protection Certificates for palonosetron hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/032 United Kingdom ➤ Subscribe PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
/2005 Austria ➤ Subscribe PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
745 Luxembourg ➤ Subscribe PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Cipla
UBS
Daiichi Sankyo
Teva
Accenture
Dow
Chubb
Cantor Fitzgerald

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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