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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 palonosetron hydrochloride 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, Mylan Institutional, Qilu Pharm Co Ltd, Sagent Pharms, Sandoz Inc, Teva Pharms Usa, Virtus Pharm, and Exela Pharma Science, and is included in eighteen 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. Eighteen suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for palonosetron hydrochloride

International Patents:	53
US Patents:	13
Tradenames:	2
Applicants:	13
NDAs:	18
Drug Master File Entries:	21
Suppliers / Packagers:	18
Bulk Api Vendors:	73
Clinical Trials:	92
Patent Applications:	484
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for palonosetron hydrochloride
DailyMed Link:	palonosetron hydrochloride at DailyMed

Pharmacology for palonosetron hydrochloride

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

Synonyms for palonosetron hydrochloride

(2R,3R,6R)-2-methyl-6-(phenylsulfanyl)-3,6-dihydro-2H-pyran-3-ol

(3aS)-2-((3S)-quinuclidin-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one hydrochloride

(3aS)-2-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-1H-benz[de]isoquinolin-1-one Hydrochloride

(3aS)-2-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-1H-benz[de]isoquinolin-1-one monohydrochloride

(3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one--hydrogen chloride (1/1)

(3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3H-benzo[de]isoquinolin-1-one hydrochloride

(3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3H-benzo[de]isoquinolin-1-one;hydrochloride.

(3as)-2-[(s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1h-benz[de]isoquinoline hydrochloride

(3aS)-2,3,3a,4,5,6-Hexahydro-2-((3S)-3-quinuclidinyl)-1H-benz(de)isoquinolin-1-one monohydrochloride

(3S)-3-[(3aS)-1-oxo-3a,4,5,6-tetrahydro-1H-benzo[de]isoquinolin-2(3H)-yl]-1-azabicyclo[2.2.2]octan-1-ium chloride

(R,S)-Palonosetron HCl

(S,R)-Palonosetron HCl

(S,S)-Palonosetron Hydrochloride

(S)-2-((S)-quinuclidin-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one hydrochloride

1021481-16-2

135729-62-3

135729-76-9

1H-Benz(de)isoquinolin-1-one, 2-(3S)-1-azabicyclo(2.2.2)oct-3-yl-2,3,3a,4,5,6-hexahydro-, monohydrochloride, (3aS)-

1H-Benz[de]isoquinolin-1-one,3,3a,4,5,6-hexahydro-, (3aS)- hydrochloride

1H-Benz[de]isoquinolin-1-one,3,3a,4,5,6-hexahydro-, [S-(R*,R*)]-, hydrochloride

1J5X5HPB4C

23310D4I19

729P623

A806977

AB0105782

AC-1293

AC1OCF9K

ACN-040771

AK162860

AKOS015895112

AKOS026751493

Aloxi

Aloxi (TN)

API0003734

BC201360

C-20102

CAS-135729-62-3

CC-33456

CCG-101081

CCG-221268

CHEBI:85157

CHEMBL1720

CPD000469233

CS-0621

CTK8F0325

D05343

DSSTox_CID_26610

DSSTox_GSID_46610

DSSTox_RID_81765

DTXSID8046610

EN300-221649

FT-0600824

HY-A0021

I14-20251

KS-00000SN1

MLS001424202

MolPort-005-932-622

MolPort-016-638-380

NC00331

NCGC00166415-01

NCGC00166415-03

NSC-743769

NSC743769

OLDRWYVIKMSFFB-SSPJITILSA-N

Onicit

Onicita

P-225

P2051

Palonosetron (Hydrochloride)

PALONOSETRON HCl

Palonosetron hydrochloride (Aloxi)

Palonosetron hydrochloride (JAN/USAN)

Palonosetron hydrochloride [USAN:JAN]

Palonosetron hydrochloride, (3R)-

Palonosetron hydrochloride, >=98% (HPLC)

Palonosetron hydrochloride, United States Pharmacopeia (USP) Reference Standard

Palonosetronhydrochloride hydrochloride

Paloxi

RL01606

RS 25233-197

RS 25259-197

RS-25259-197

RTC-070923

s3050

SAM001246791

SCHEMBL182478

SMR000469233

TC-070923

Tox21_112421

Tox21_112421_1

UNII-1J5X5HPB4C

UNII-23310D4I19

W-5346

Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS
		EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS
		0.25MG/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.

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
Helsinn Hlthcare	ALOXI	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	021372-002	Feb 29, 2008	AP	RX	Yes	Yes					Y
Hospira Inc	PALONOSETRON HYDROCHLORIDE	palonosetron hydrochloride	INJECTABLE;INTRAVENOUS	207005-001	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
Canada	2573228
Georgia, Republic of	P20084445
Japan	5461763

Supplementary Protection Certificates for palonosetron hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1035115	92745	Luxembourg		PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
0430190	SPC/GB05/032	United Kingdom		PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
0430190	18/2005	Austria		PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322