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Generated: November 16, 2018

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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, Cipla Ltd, 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 seventeen NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for palonosetron hydrochloride. Sixteen suppliers are listed for this compound. There are four tentative approvals for this compound.

Pharmacology for palonosetron hydrochloride
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-[(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
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
MFCD00939524
MLS001424202
MolPort-005-932-622
MolPort-016-638-380
NC00331
NCGC00166415-01
NCGC00166415-03
NSC-743769
NSC743769
OLDRWYVIKMSFFB-SSPJITILSA-N
Onicit
Onicita
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-25259-197
RTC-070923
s3050
SAM001246791
SCHEMBL182478
SMR000469233
ST51052757
TC-070923
Tox21_112421
Tox21_112421_1
UNII-1J5X5HPB4C
UNII-23310D4I19
W-5346
Tentative approvals for PALONOSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE;INTRAVENOUS
➤ Sign Up➤ Sign UpEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE;INTRAVENOUS
➤ Sign Up➤ Sign Up0.25MG/5MLINJECTABLE;INJECTION

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
Exela Pharma Science PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride SOLUTION;INTRAVENOUS 207963-001 Aug 22, 2016 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sandoz Inc PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 202521-001 Oct 13, 2015 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Dr Reddys Labs Ltd PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 201533-001 Apr 21, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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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 ➤ Sign Up ➤ Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ➤ Sign Up ➤ Sign Up
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for palonosetron hydrochloride

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

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
McKinsey
Merck
Federal Trade Commission
Cipla
McKesson
Express Scripts
Fuji
Deloitte

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