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

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Last Updated: November 14, 2019

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Paliperidone - Generic Drug Details

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

Paliperidone is the generic ingredient in four branded drugs marketed by Janssen Pharms, Actavis Labs Fl Inc, Inventia, Mylan, and Sun Pharm, and is included in seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for paliperidone

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Recent Clinical Trials for paliperidone

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

See all paliperidone clinical trials

Recent Litigation for paliperidone

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District Court Litigation
Case NameDate
TEVA PHARMACEUTICALS USA, INC. v. LEAVITT2008-03-04

See all paliperidone litigation

Pharmacology for paliperidone
Synonyms for paliperidone
(+/-)-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 (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

US Patents and Regulatory Information for paliperidone

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 022264-004 Jul 31, 2009 RX Yes Yes   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 paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-001 Dec 19, 2006 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharm PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 205618-001 Apr 6, 2018 AB RX No 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-006 Aug 26, 2008   Start Trial   Start Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-003 Dec 19, 2006   Start Trial   Start Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-002 Dec 19, 2006   Start Trial   Start Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-001 Dec 19, 2006   Start Trial   Start Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-004 Dec 19, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.