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Last Updated: August 7, 2020

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 patent protection?

Palonosetron hydrochloride is the generic ingredient in two branded drugs marketed by Helsinn Hlthcare, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Ingenus Pharms Llc, Mylan Institutional, Qilu, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, Virtus Pharm, and Hikma, and is included in nineteen 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. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for palonosetron hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Heron TherapeuticsPhase 2
University of Alabama at BirminghamPhase 2
Daegu Catholic University Medical CenterN/A

See all palonosetron hydrochloride clinical trials

Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.25MG(BASE)/5MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for palonosetron hydrochloride
Paragraph IV (Patent) Challenges for PALONOSETRON HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ALOXI INJECTABLE;INTRAVENOUS palonosetron hydrochloride 021372 2011-05-27

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
Teva Pharms Usa PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 090713-002 Mar 23, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Qilu PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 205648-002 Sep 19, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 207005-002 Sep 19, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Institutional PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 206416-001 Sep 19, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
>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 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   Start Trial   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003   Start Trial   Start Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for palonosetron hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2785706 LUC00158 Luxembourg   Start Trial PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0430190 18/2005 Austria   Start Trial PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
1035115 92745 Luxembourg   Start Trial PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
0430190 SPC/GB05/032 United Kingdom   Start Trial PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Mallinckrodt
Colorcon
AstraZeneca
Johnson and Johnson

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