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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 paliperidone patent protection?

Paliperidone is the generic ingredient in four branded drugs marketed by Janssen Pharms, Actavis Labs Fl Inc, Mylan Pharms Inc, and Sun Pharma Global, and is included in six 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. Eleven suppliers are listed for this compound.

Summary for paliperidone

US Patents:	3
Tradenames:	4
Applicants:	4
NDAs:	6
Drug Master File Entries:	38
Suppliers / Packagers:	11
Bulk Api Vendors:	106
Clinical Trials:	167
Patent Applications:	514
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for paliperidone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paliperidone
DailyMed Link:	paliperidone at DailyMed

Pharmacology for paliperidone

Drug Class

Atypical Antipsychotic

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
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009		RX	Yes	No
Sun Pharma Global	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	205618-002	Apr 6, 2018	AB	RX	No	No
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015		RX	Yes	Yes
Sun Pharma Global	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	205618-004	Apr 6, 2018	AB	RX	No	No

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	021999-002	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-003	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-004	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-006	Aug 26, 2008
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-001	Dec 19, 2006