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Last Updated: December 7, 2021

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PALONOSETRON HYDROCHLORIDE Drug Patent Profile


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Which patents cover Palonosetron Hydrochloride, and when can generic versions of Palonosetron Hydrochloride launch?

Palonosetron Hydrochloride is a drug marketed by Accord Hlthcare, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Eugia Pharma, 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.

The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Palonosetron Hydrochloride

A generic version of PALONOSETRON HYDROCHLORIDE was approved as palonosetron hydrochloride by SANDOZ INC on October 13th, 2015.

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Drug patent expirations by year for PALONOSETRON HYDROCHLORIDE
Recent Clinical Trials for PALONOSETRON HYDROCHLORIDE

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

SponsorPhase
Fudan UniversityPhase 3
Sixth Affiliated Hospital, Sun Yat-sen UniversityPhase 3
Helsinn Healthcare SAPhase 4

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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
Accord Hlthcare PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 204615-001 Mar 15, 2021 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz Inc PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 202521-001 Oct 13, 2015 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fresenius Kabi Usa PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride SOLUTION;INTRAVENOUS 208109-001 Nov 21, 2017 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Eugia Pharma PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 204702-001 Nov 6, 2018 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys Labs Ltd PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 201533-002 Apr 21, 2016 AP RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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.