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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, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, 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. 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 twenty-one 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:	14
NDAs:	19
Drug Master File Entries:	21
Suppliers / Packagers:	19
Bulk Api Vendors:	85
Clinical Trials:	108
Patent Applications:	580
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
Instituto Brasileiro de Controle do Cancer	Phase 2
Theodor Bilharz Research Institute	Phase 4
Cairo University	Phase 4

See all palonosetron hydrochloride clinical trials

Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		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	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
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003	AP	RX	Yes	Yes					Y
Fresenius Kabi Usa	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	206802-001	Sep 19, 2018	AP	RX	No	No
Mylan Institutional	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	206416-001	Sep 19, 2018	AP	RX	No	No

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
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-001	Jul 25, 2003

International Patents for palonosetron hydrochloride

Country	Patent Number	Estimated Expiration
Costa Rica	7921
Spain	2315635
China	1758911

Supplementary Protection Certificates for palonosetron hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	122020000046	Germany		PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
1035115	92745	Luxembourg		PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
2785706	LUC00158	Luxembourg		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318