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Last Updated: March 19, 2024

PALONOSETRON HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for palonosetron hydrochloride and what is the scope of freedom to operate?

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
Qilu Pharm Hainan PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 205648-001 Sep 19, 2018 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
Fresenius Kabi Usa PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride SOLUTION;INTRAVENOUS 208109-001 Nov 21, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
>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
0430190 18/2005 Austria ⤷  Try a Trial PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
0430190 SPC/GB05/032 United Kingdom ⤷  Try a 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
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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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 verification 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.