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Last Updated: November 13, 2019

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INVEGA SUSTENNA Drug Profile

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Which patents cover Invega Sustenna, and when can generic versions of Invega Sustenna launch?

Invega Sustenna is a drug marketed by Janssen Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in thirty-seven countries.

The generic ingredient in INVEGA SUSTENNA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

Drug patent expirations by year for INVEGA SUSTENNA
Drug Prices for INVEGA SUSTENNA

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Recent Clinical Trials for INVEGA SUSTENNA

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SponsorPhase
Luye Pharma Group Ltd.Phase 1
Alkermes, Inc.Phase 3
Otsuka America PharmaceuticalPhase 4

See all INVEGA SUSTENNA clinical trials

Recent Litigation for INVEGA SUSTENNA

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 INVEGA SUSTENNA litigation

Pharmacology for INVEGA SUSTENNA
Synonyms for INVEGA SUSTENNA
(+/-)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
(9RS)-3-(2-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl))ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido(1,2-a)pyrimidin-4-one
(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one (9-Hydroxyrisperidone)
130049-84-2
130049-86-4
144598-75-4
147687-18-1
3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-(2-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]ETHYL)-9-HYDROXY-2-METHYL-4H,6H,7H,8H,9H-PYRIDO[1,2-A]PYRIMIDIN-4-ONE
3-[ 2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
3-[ 2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin4-one
3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]-pyrimidin-4-one
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one, 9-Hydroxyrisperidone
3-[2-[4-(6-Fluoro-1,2-Benzisoxazol-3-yl)-1-Piperidinyl]Ethyl]-9-Hydroxy-6,7,8,9-Tetrahydro-2-Methyl-4H-Pyrido[1,2-a]-Pyrimidin-4-One
3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)-1-piperidyl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-[2-[4-(6-FLUOROBENZO[D]ISOXAZOL-3-YL)-1-PIPERIDYL]ETHYL]-7-HYDROXY-4-METHYL-1,5-DIAZABI-CYCLO[4.4.0]DECA-3,5-DIEN-2-ONE
3-{2-[4-(6-fluoro-1,2-benzoisoxazol-3-yl)-1-piperidinyl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-alpha]pyrimidin-4-one
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-4H,6H,7H,8H,9H-pyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-9-hydroxy-2-methyl-6,7,8,9- tetrahydro-pyrido[1,2-a]pyrimidin-4-one
4H-Pyrido(1,2-a)pyrimidin-4-one, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8-tetrahydro-9-hydroxy-2-methyl-
4H-Pyrido(1,2-a)pyrimidin-4-one, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-
4H-Pyrido(2,1-a)pyrimidin-4-one, 6,7,8,9-tetrahydro-3-(2-(4-(6-fluro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-2-methyl-
4H-Pyrido[1,2-a]pyrimidin-4-one, 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-
4H-yrido[1,2-]yrimidin-4-ne, 3-2-4-(6-luoro-1,2-enzisoxazol-3-l)-1-iperidinyl]thyl]-6,7,8,9-etrahydro-9-ydroxy-2-ethyl-
598P754
6,7,8,9-Tetrahydro-3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-2-methyl-4H-pyrido[2,1-a]pyrimidin-4-one
6,7,8,9-Tetrahydro-3-(2-(4-(6-fluro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-2-methyl-4H-pyrido[2,1-a]pyrimidin-4-one
838F01T721
9-Hydroxy risperidone
9-hydroxy risperidone
9-Hydroxy Risperidone-d4 (Paliperidone D4)
9-Hydroxyrisperidone
9-Hydroxyrisperidone 1.0 mg/ml in Methanol
9-Hydroxyrisperidone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
9-Hydroxyrisperidone, 98%
9-OH-risperidone
AB0018636
AB1010913
ABP000395
AC-1282
AC1L3GS8
AKOS005266713
AKOS016339656
AKOS025392164
AN-759
ANW-42875
AOB1667
AS-13860
BC228519
BC677689
BCP02338
BCP9001047
BCPP000132
BDBM50252513
BRD-A99888680-001-04-6
C21516
CCG-221866
CHEBI:83804
CHEMBL1621
CM14424
CS-0386
CTK8B3649
D05339
DB01267
FT-0080561
FT-0600425
GTPL7258
HMS3261B06
HSDB 8148
HY-A0019
I14-1945
Invega
Invega (TN)
J10457
JNS-007ER
KS-00000W1B
KS-1279
L023985
LP00562
LS-134195
MCULE-5597043685
MFCD00871802
MFCD09955571
MLS004773953
MolPort-003-848-059
MolPort-020-313-413
NCGC00186014-01
NCGC00261247-01
P1897
Paliperidone
Paliperidone (JAN/USAN/INN)
Paliperidone [INN]
Paliperidone [USAN:INN:BAN:JAN]
Paliperidone, >=98% (HPLC)
Paliperidone, United States Pharmacopeia (USP) Reference Standard
Paliperidone/Invega
PALLIPERIDONE
PB27526
PMXMIIMHBWHSKN-UHFFFAOYSA-N
Q-101425
Q-4343
R 76477
R-76477
RAC 9-HYDROXY RISPERIDONE
RL01805
RO-76477
RO76477
RTC-030009
s1724
S451
SC-08807
SCHEMBL436689
SMR001456280
SR-02000000862
SR-02000000862-3
ST24030055
TC-030009
Tox21_500562
UNII-838F01T721
YF10040
Paragraph IV (Patent) Challenges for INVEGA SUSTENNA
Tradename Dosage Ingredient NDA Submissiondate
INVEGA SUSTENNA SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR paliperidone palmitate 022264 2017-11-21

US Patents and Regulatory Information for INVEGA SUSTENNA

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 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
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 022264-003 Jul 31, 2009 RX Yes No   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 022264-002 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 INVEGA SUSTENNA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 022264-004 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 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 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 022264-001 Jul 31, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for INVEGA SUSTENNA

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 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
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 2011/021 Ireland   Start Trial PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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