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Generated: May 25, 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, Dr Reddys Labs Ltd, Sandoz Inc, Teva Pharms Usa, Exela Pharma Science, and Fresenius Kabi Usa, and is included in eight 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. Eight 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
➤ Try a Free Trial➤ Try a Free TrialEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)INJECTABLE;INTRAVENOUS
➤ Try a Free Trial➤ Try a Free TrialEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)INJECTABLE;INTRAVENOUS
➤ Try a Free Trial➤ Try a Free Trial0.25MG/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
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Dr Reddys Labs Ltd PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride SOLUTION;INTRAVENOUS 203050-002 Mar 1, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Ltd PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride SOLUTION;INTRAVENOUS 203050-001 Mar 1, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-002 Feb 29, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Helsinn Hlthcare ALOXI palonosetron hydrochloride INJECTABLE;INTRAVENOUS 021372-001 Jul 25, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for palonosetron hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,308,266 Liquid pharmaceutical formulations of palonosetron ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for palonosetron hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
745 Luxembourg ➤ Try a Free Trial PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
C/GB05/032 United Kingdom ➤ Try a Free 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
/2005 Austria ➤ Try a Free Trial PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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