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Last Updated: March 28, 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 two branded drugs marketed by Helsinn Hlthcare, Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Mylan Institutional, Nanjing King-friend, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Avyxa Pharma, and Hikma, 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. 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
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Samsung Medical CenterN/A
The Guthrie ClinicPhase 4

See all palonosetron hydrochloride clinical trials

Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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 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
Dr Reddys PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 201533-002 Apr 21, 2016 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 206916-001 Nov 12, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 206396-001 Sep 19, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for palonosetron hydrochloride

Country Patent Number Title Estimated Expiration
Georgia, Republic of P20084445 LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON ⤷  Try a Trial
European Patent Office 1601359 FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRON (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON) ⤷  Try a Trial
Portugal 1601359 ⤷  Try a Trial
European Patent Office 2008659 Formules pharmaceutiques liquides de palonosĂ©tron (Liquid pharmaceutical formulations of palonosetron) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for palonosetron hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2785706 122020000046 Germany ⤷  Try a Trial PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
1035115 92745 Luxembourg ⤷  Try a Trial PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
0430190 18/2005 Austria ⤷  Try a Trial PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
2785706 2020C/516 Belgium ⤷  Try a Trial PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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