Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald
Chubb
Citi
Johnson and Johnson
Medtronic
Queensland Health
Chinese Patent Office
Mallinckrodt
Covington

Generated: October 24, 2017

DrugPatentWatch Database Preview

Palonosetron hydrochloride - Generic Drug Details

« Back to Dashboard

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 Sandoz Inc, Helsinn Hlthcare, Dr Reddys Labs Ltd, 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 and three supplementary protection certificates in three 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 Generic Name: palonosetron hydrochloride

US Patents:13
Tradenames:2
Applicants:4
NDAs:6
Drug Master File Entries: see list21
Suppliers / Packagers: see list2
Bulk Api Vendors: see list44
Clinical Trials: see list2,357
Patent Applications: see list375
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:palonosetron hydrochloride at DailyMed

Pharmacology for Ingredient: palonosetron hydrochloride

Tentative approvals for PALONOSETRON HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE;INTRAVENOUS
u► SubscribeEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE;INTRAVENOUS
u► Subscribe0.25MG/5MLINJECTABLE;INJECTION
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;INTRAVENOUS021372-002Feb 29, 2008APRXYesYes► Subscribe► SubscribeY► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-002Feb 29, 2008APRXYesYes► Subscribe► SubscribeY► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-001Jul 25, 2003APRXYesYes► Subscribe► SubscribeY► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-002Feb 29, 2008APRXYesYes► Subscribe► Subscribe► Subscribe
Sandoz Inc
PALONOSETRON HYDROCHLORIDE
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS202521-001Oct 13, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-002Feb 29, 2008APRXYesYes► Subscribe► SubscribeY► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-001Jul 25, 2003APRXYesYes► Subscribe► SubscribeY► Subscribe
Dr Reddys Labs Ltd
PALONOSETRON HYDROCHLORIDE
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS201533-002Apr 21, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-002Feb 29, 2008APRXYesYes► Subscribe► SubscribeY► Subscribe
Exela Pharma Science
PALONOSETRON HYDROCHLORIDE
palonosetron hydrochloride
SOLUTION;INTRAVENOUS207963-001Aug 22, 2016RXNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: palonosetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
CAPSULE;ORAL022233-001Aug 22, 2008► Subscribe► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-001Jul 25, 2003► Subscribe► Subscribe
Helsinn Hlthcare
ALOXI
palonosetron hydrochloride
INJECTABLE;INTRAVENOUS021372-002Feb 29, 2008► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: 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
9,308,266Liquid pharmaceutical formulations of palonosetron► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: palonosetron hydrochloride

Country Document Number Estimated Expiration
South Africa200506917► Subscribe
Taiwan200418517► Subscribe
BrazilPI0407121► Subscribe
Germany602004016967► Subscribe
South Korea20050104363► Subscribe
Japan5461763► Subscribe
Canada2514224► Subscribe
EcuadorSP055938► Subscribe
Norway20053987► Subscribe
Slovenia1601359► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: PALONOSETRON HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
745Luxembourg► SubscribePRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
/2005Austria► SubscribePRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Accenture
Cipla
UBS
Fuji
Federal Trade Commission
Healthtrust
Cerilliant
Boehringer Ingelheim
AstraZeneca
Teva

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot