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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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for paliperidone. Ten suppliers are listed for this compound.

Summary for paliperidone

US Patents:	2
Tradenames:	4
Applicants:	4
NDAs:	6
Drug Master File Entries:	36
Suppliers / Packagers:	10
Bulk Api Vendors:	99
Clinical Trials:	161
Patent Applications:	498
Formulation / Manufacturing:	see details
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-Hydroxyrisperidone

9-Hydroxyrisperidone 1.0 mg/ml in Methanol

9-OH-risperidone

AB0018636

AB1010913

ABP000395

AC-1282

AC1L3GS8

AK-77508

AKOS005266713

AKOS016339656

AKOS025392164

AN-759

ANW-42875

AOB1667

AS-13860

BC228519

BC677689

BCP9001047

BCPP000132

BDBM50252513

C21516

CCG-221866

CHEBI:83804

CHEMBL1621

CM14424

CS-0386

CTK8B3649

D05339

D0B3UJ

DB01267

FT-0080561

FT-0600425

GTPL7258

HE068045

HE128870

HE290228

HMS3261B06

HSDB 8148

HY-A0019

I14-1945

Invega

Invega (TN)

Invega Sustenna

J10457

JNS-007ER

JNS-010

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 (depot injection, NanoCrystal)

Paliperidone (depot injection, NanoCrystal), Johnson & Johnson

Paliperidone (injectable, NanoCrystal), Elan

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

RO-76477

RO76477

RTC-030009

s1724

S451

SC-08807

SCHEMBL436689

SMR001456280

SR-02000000862

SR-02000000862-3

ST24030055

TC-030009

Tox21_500562

UNII-838F01T721

xeplion

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	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-004	Dec 19, 2006		DISCN	Yes	No
Actavis Labs Fl Inc	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	202645-004	Aug 3, 2015	AB	RX	No	No
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-003	Dec 19, 2006	AB	RX	Yes	No
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009		RX	Yes	No

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

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