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Last Updated: April 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.

Summary for PALONOSETRON HYDROCHLORIDE

International Patents:	53
US Patents:	13
Tradenames:	2
Applicants:	19
NDAs:	23
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	122
Patent Applications:	1,121
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PALONOSETRON HYDROCHLORIDE
What excipients (inactive ingredients) are in PALONOSETRON HYDROCHLORIDE?	PALONOSETRON HYDROCHLORIDE excipients list
DailyMed Link:	PALONOSETRON HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PALONOSETRON HYDROCHLORIDE

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Samsung Medical Center	N/A
The Guthrie Clinic	Phase 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 Trial	0.25MG(BASE)/5ML	INJECTABLE;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

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
Novast Labs	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	208789-001	May 22, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Accord Hlthcare	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	204615-001	Mar 15, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eugia Pharma	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	204702-001	Nov 6, 2018	AP	RX	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
Avet Lifesciences	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	202951-001	Jun 29, 2021		RX	No	Yes	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	021372-001	Jul 25, 2003	⤷ Try a Trial	⤷ Try a Trial
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	021372-002	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

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Country	Patent Number	Title	Estimated Expiration
Canada	2514224	FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)	⤷ Try a Trial
Ukraine	90449	ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ПАЛОНОСЕТРОНА;РІДКІ ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ ПАЛОНОСЕТРОНУ (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)	⤷ Try a Trial
Japan	2011236242	LIQUID PHARMACEUTICAL FORMULATION OF PALONOSETRON	⤷ Try a Trial
Georgia, Republic of	P20084445	LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON	⤷ Try a Trial
Eurasian Patent Organization	014066	ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ПАЛОНОСЕТРОНА (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON)	⤷ Try a Trial
Taiwan	I342212		⤷ Try a Trial
Hong Kong	1076401	Liquid pharmaceutical formulations of palonosetron	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PALONOSETRON HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	2020C/516	Belgium	⤷ Try a Trial	PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
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
1035115	92745	Luxembourg	⤷ Try a Trial	PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
2785706	LUC00158	Luxembourg	⤷ Try a Trial	PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
2785706	C02785706/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
2785706	122020000046	Germany	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
0430190	18/2005	Austria	⤷ Try a Trial	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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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.