Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 7, 2019

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PALIPERIDONE PALMITATE - Generic Drug Details

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What are the generic sources for paliperidone palmitate and what is the scope of patent protection?

Paliperidone palmitate is the generic ingredient in two branded drugs marketed by Janssen Pharms and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paliperidone palmitate has seventy-nine patent family members in thirty-eight countries.

There are thirty-eight drug master file entries for paliperidone palmitate. Two suppliers are listed for this compound.

Recent Clinical Trials for PALIPERIDONE PALMITATE

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SponsorPhase
The University of Hong KongPhase 2/Phase 3
North District HospitalPhase 2/Phase 3
Queen Mary Hospital, Hong KongPhase 2/Phase 3

See all PALIPERIDONE PALMITATE clinical trials

Recent Litigation for PALIPERIDONE PALMITATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Janssen Pharmaceuticals, Inc. v. Mylan Laboratories Limited2019-08-09
Par Pharmaceutical, Inc. v. Twi Pharmaceuticals, Inc.2014-04-01
JANSSEN PHARMACEUTICALS, INC. v. MYLAN LABORATORIES LIMITED

See all PALIPERIDONE PALMITATE litigation

Pharmacology for PALIPERIDONE PALMITATE
Medical Subject Heading (MeSH) Categories for PALIPERIDONE PALMITATE
Synonyms for PALIPERIDONE PALMITATE
(9R)-3-[2-[4-(6-Fluoro-1,2-benzoisoxazole-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-9-(palmitoyloxy)-4H-pyrido[1,2-a]pyrimidine-4-one
(9R)-3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate
(9RS)-3-(2-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido(1,2-a)pyrimidin-9-yl hexadecanoate
(R)-paliperidone hexadecanoate
(R)-paliperidone palmitate
199739-10-1
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate
44W02N396B
9-Hydroxyrisperidone Palmitate
AKOS030526057
BCP08473
CHEBI:83808
CHEBI:83810
CHEMBL2107360
D05340
FT-0673476
Hexadecanoic Acid 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido[1,2-a]pyrimidin-9-yl Ester
Hexadecanoic acid, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido(1,2-a)pyrimidin-9-yl ester
Invega Trinza
JNS 010
MolPort-044-559-897
Paliperidone palmitate (JAN/USAN)
Paliperidone Palmitate [USAN]
PALPERIDONE PALMITATE
R8P8USM8FR
Ro 92670
RO92670
SB17398
SC-84561
SCHEMBL12415674
SCHEMBL18131955
SCHEMBL1871384
Trevicta (TN)
Trinza
UNII-44W02N396B
UNII-R8P8USM8FR
Xeplion (TN)
ZINC68151119
Paragraph IV (Patent) Challenges for PALIPERIDONE PALMITATE
Tradename Dosage Ingredient NDA Submissiondate
INVEGA SUSTENNA SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR paliperidone palmitate 022264 2017-11-21

US Patents and Regulatory Information for PALIPERIDONE PALMITATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-003 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-003 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start 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 PALIPERIDONE PALMITATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-003 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-003 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PALIPERIDONE PALMITATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0368388 07C0044 France   Start Trial PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
0904081 2011/021 Ireland   Start Trial PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0904081 11C0035 France   Start Trial PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
0368388 SPC/GB07/065 United Kingdom   Start Trial PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
0904081 SPC/GB11/044 United Kingdom   Start Trial PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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