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Last Updated: December 3, 2022

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, Accord Hlthcare, Baxter Hlthcare Corp, Cipla, Dr Reddys, Emcure Pharms Ltd, Eugia Pharma, Fresenius Kabi Usa, Hospira, Ingenus Pharms Llc, Mylan Institutional, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, Virtus Pharm, and Hikma, and is included in twenty-two 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. Nineteen 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
The Guthrie ClinicPhase 4
Fujian Shengdi Pharmaceutical Co., Ltd.Phase 3
Selcuk UniversityPhase 3

See all palonosetron hydrochloride clinical trials

Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing0.25MG(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
Emcure Pharms Ltd PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 202951-001 Jun 29, 2021 RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Fresenius Kabi Usa PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 206801-001 Sep 19, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 021372-001 Jul 25, 2003 See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride CAPSULE;ORAL 022233-001 Aug 22, 2008 See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for palonosetron hydrochloride

Country Patent Number Title Estimated Expiration
Uruguay 28175 FORMULACIONES FARMACEUTICAS LIQUIDAS DE PALONOSETRON See Plans and Pricing
European Patent Office 2008659 Formules pharmaceutiques liquides de palonos├ętron (Liquid pharmaceutical formulations of palonosetron) See Plans and Pricing
Taiwan 200418517 Liquid pharmaceutical formulations of palonosetron See Plans and Pricing
Hong Kong 1076401 Liquid pharmaceutical formulations of palonosetron See Plans and Pricing
China 102813621 Liquid pharmaceutical formulations of palonosetron See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for palonosetron hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2785706 2020C/516 Belgium See Plans and Pricing PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0430190 SPC/GB05/032 United Kingdom See Plans and Pricing PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
1035115 92745 Luxembourg See Plans and Pricing PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
2785706 LUC00158 Luxembourg See Plans and Pricing PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
2785706 122020000046 Germany See Plans and Pricing PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
McKinsey
Colorcon
Boehringer Ingelheim
Express Scripts

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