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Last Updated: November 4, 2024

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 three branded drugs marketed by Helsinn Hlthcare, Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Hikma, and Avyxa Holdings, and is included in twenty-three 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 nineteen drug master file entries for palonosetron hydrochloride. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for palonosetron hydrochloride
Recent Clinical Trials for palonosetron hydrochloride

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

SponsorPhase
SanQing JinN/A
Sichuan Cancer Hospital and Research InstituteN/A
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4

See all palonosetron hydrochloride clinical trials

Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up0.25MG(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 Strength NDA ANDAs Submitted Submissiondate
ALOXI Injection palonosetron hydrochloride 0.05 mg/mL, 1.5 mL and 5 mL vials 021372 3 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
Mylan Institutional PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 206416-001 Sep 19, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Avyxa Holdings POSFREA palonosetron hydrochloride SOLUTION;INTRAVENOUS 203050-001 Mar 1, 2016 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Avet Lifesciences PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 202951-001 Jun 29, 2021 RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sagent Pharms Inc PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 204289-001 Sep 19, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Sign Up ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ⤷  Sign Up ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ⤷  Sign Up ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Sign Up ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Sign Up ⤷  Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for palonosetron hydrochloride

Country Patent Number Title Estimated Expiration
Japan 2006516583 ⤷  Sign Up
Ukraine 90449 ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ПАЛОНОСЕТРОНА;РІДКІ ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ ПАЛОНОСЕТРОНУ (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON) ⤷  Sign Up
New Zealand 541533 Liquid pharmaceutical formulations of palonosetron ⤷  Sign Up
Eurasian Patent Organization 200501203 ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ПАЛОНОСЕТРОНА ⤷  Sign Up
South Korea 101113084 ⤷  Sign Up
Canada 2573194 FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for palonosetron hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2785706 C02785706/01 Switzerland ⤷  Sign Up PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
0430190 SPC/GB05/032 United Kingdom ⤷  Sign Up PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
2785706 2020C/516 Belgium ⤷  Sign Up PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
2785706 LUC00158 Luxembourg ⤷  Sign Up PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
1035115 92745 Luxembourg ⤷  Sign Up PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
0430190 18/2005 Austria ⤷  Sign Up PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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