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Generated: June 22, 2017
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 fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 14 |
| Applicants: | 4 |
| NDAs: | 6 |
| Drug Master File Entries: see list | 21 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 44 |
| Clinical Trials: see list | 2,312 |
| Patent Applications: see list | 338 |
| Therapeutic Class: | Antiemetics |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | palonosetron hydrochloride at DailyMed |
| Drug Class | Serotonin-3 Receptor Antagonist |
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS |
| ► Subscribe | ► Subscribe | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS |
| ► Subscribe | ► Subscribe | 0.25MG/5ML | INJECTABLE;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;INTRAVENOUS | 021372-001 | Jul 25, 2003 | AP | RX | Yes | Yes | 7,960,424*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | AP | RX | Yes | Yes | 7,960,424*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | AP | RX | Yes | Yes | 7,947,724*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Dr Reddys Labs Ltd | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 201533-001 | Apr 21, 2016 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| 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 | ► Subscribe | ||||||||||||||||||||||
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | 5,202,333*PED | ► Subscribe | ||||||||||||||||||||||
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | 5,202,333*PED | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eurasian Patent Organization | 014066 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2514224 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20050104363 | ► Subscribe | |||||||||||||||||||||||||||
| China | 102813621 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2011236242 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 745 | Luxembourg | ► Subscribe | PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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