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Risperidone - Generic Drug Details

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What are the generic drug sources for risperidone and what is the scope of risperidone freedom to operate?

Risperidone is the generic ingredient in four branded drugs marketed by Indivior Inc, Janssen Pharms, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Bio Pharm Inc, Lannett Co Inc, Lifestar Pharma, Precision Dose, Taro, Tris Pharma Inc, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Ajanta Pharma Ltd, Aurobindo Pharma, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, Pliva Hrvatska Doo, Prinston Inc, Ratiopharm, Renata, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-nine NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for risperidone. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for risperidone

US Patents:	9
Tradenames:	4
Applicants:	38
NDAs:	49
Drug Master File Entries:	30
Suppliers / Packagers:	56
Bulk Api Vendors:	100
Clinical Trials:	478
Patent Applications:	6,578
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for risperidone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for risperidone
DailyMed Link:	risperidone at DailyMed

Pharmacology for risperidone

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for risperidone

Antipsychotic Agents

Dopamine Antagonists

Serotonin Antagonists

Synonyms for risperidone

(risperidone)3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-a]pyrimidin-4-one

106266-06-2

2-(2-(4-(benzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-7,8,9,9a-tetrahydro-1H-pyrido[1,2-a]pyrimidin-4(6H)-one

2-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-6,7,8,8a-tetrahydro-5H-naphthalen-1-one

3-?[2-?[4-?(6-?FLUORO-?1,?2-?BENZISOXAZOL-?3-?YL)-?1-?PIPERIDINYL]ETHYL]-?6,?7,?8,?9-?TETRAHYDRO-?2-?METHYL-?4H-?PYRIDO[1,?2-?A]PYRIMIDIN-?4-?ONE

3-(2-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino)ethyl)-6,7,8,9-tetrahydro-2-methyl-4H-pyrido(1,2-a)pyrimidin-4-one

3-(2-(4-(6-Fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-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)-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)-2-methyl-6,7,8,9-tetrahydro-pyrido[

3-(2-[4-(6-FLUORO-BENZO[D]ISOXAZOL-3-YL)-PIPERIDIN-1-YL]-ETHYL)-2-METHYL-6,7,8,9-TETRAHYDRO-PYRIDO[1,2-A]PYRIMIDIN-4-ONE

3-(2-[4-(6-fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl)-2-methyl-6,7,8,9-tetrahydropyrido[1,

3-[2-[-4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-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-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-2-methyl4H-pyrido[1,2-a]pyrimidin-4-one

3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidiny]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one

3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]-6,7,8,9-tetrahydro-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-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-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one

3-[2-[4-(6-FLUORO-1,2-BENZISOXAZOL-3-YL)-PIPERIDIN-1-YL]ETHYL]-6,7,8,9-TETRAHYDRO-2-METHYL-4H-PYRIDO[1,2-A]PYRIMIDIN-4-ONE

3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperi-dino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]-pyrimidin-4-one

3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-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)-1-piperidinyl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one

3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)-1-piperidyl]ethyl]-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]-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]-2-methyl-6,7,8,9-tetrahydropyrido[2,1-b]pyrimidin-4-one

3-[2-[4-(6-fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,

3-[2-[4(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-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-2-methyl4H-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-2-methyl-4H-pyrido[1,2-a]pyrimid-in-4-one

3-{2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl}-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one

3-{2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one

3-{2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl}-6,7,8,9-tetrahydro-2-methylpyrido[1,2-a]pyrimidin-4-one

3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-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}-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one

3-{2-[4-(6-FLUORO-BENZO[D]ISOXAZOL-3-YL)-PIPERIDIN-1-YL]-ETHYL}-2-METHYL-6,7,8,9-TETRAHYDRO-PYRIDO[1,2-A]PYRIMIDIN-4-ONE

3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-a]pyrimidin-4-one (Resperidone)

3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-a]pyrimidin-4-one (risperidone)

3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-a]pyrimidin-4-one(risperidone)

3-{2-[4-(6-Fluoro-benzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one

3-{2-[4-(6-fluorobenzo[d]isoxazol-3-yl)-piperidin-1-yl]-ethyl}-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one

4-[2-[4-(6-fluorobenzo[d]isoxazol-3-yl)-1-piperidyl]ethyl]-3-methyl-2,6-diazabicyclo[4.4.0]deca-1,3-dien-5-one

4767-EP2269990A1

4767-EP2272537A2

4767-EP2272841A1

4767-EP2275420A1

4767-EP2275423A1

4767-EP2280008A2

4767-EP2280010A2

4767-EP2298731A1

4767-EP2298776A1

4767-EP2301936A1

4767-EP2308867A2

4767-EP2308870A2

4767-EP2308875A1

4767-EP2316836A1

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-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-2-methyl-

4H-Pyrido(1,2-a)pyrimidin-4-one, 6,7,8,9-tetrahydro-3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-2-methyl-

4H-Pyrido[1,2-a]pyrimidin-4-one, 3-[2-[4-(6-fluoro-1,2-benz-isoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-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-2-methyl-

5-[2-(4-Benzo[d]isothiazol-3-yl-piperazin-1-yl)-ethyl]-6-methyl-1,3-dihydro-indol-2-one(Norastemizole)

66R062

A801409

AB0004623

AB00514010

AB00514010_13

AB00514010_14

AB00514010-09

AB00514010-11

AB00514010-12

AC-1306

AC1L1JJU

ACT04270

AK172045

AKOS005577302

AN-15065

ANW-42874

Apexidone

API0004081

BC206675

BDBM50001885

Belivon

BG0309

BIDD:GT0262

Bio-0092

BRD-K53857191-001-04-5

BRN 4891881

C-21900

C23H27FN4O2

CAS-106266-06-2

CC-34268

CCG-100930

CHEBI:8871

CHEMBL85

Consta, Risperdal

CPD000466323

CR0023

CS-1619

D00426

D01AZG

DB00734

DR002455

DSSTox_CID_25193

DSSTox_GSID_45193

DSSTox_RID_80740

DTXSID8045193

EU-0101074

FT-0631037

GTPL96

HE128871

HE293166

HE293167

HMS1571M19

HMS2051H07

HMS2089C22

HMS2098M19

HMS2233O11

HMS3373M18

HMS3393H07

HMS3657G13

HSDB 7580

HY-11018

I01-1156

J-001555

J10290

Jsp000573

KS-00000760

KS-1106

L000510

L6UH7ZF8HC

Lopac-R-118

LS-134196

MCULE-4027175053

MFCD00274576

MLS000759429

MLS001165758

MLS001424081

MolPort-002-885-858

NC00180

NCGC00015883-01

NCGC00015883-02

NCGC00015883-03

NCGC00015883-04

NCGC00015883-05

NCGC00015883-06

NCGC00015883-07

NCGC00015883-08

NCGC00015883-11

NCGC00094352-01

NCGC00094352-02

NCGC00094352-03

NCGC00179257-01

NP-202

NSC-759895

NSC759895

PB26023

Pharmakon1600-01506038

Prestwick0_001029

Prestwick1_001029

Psychodal

PYR332

Q-4040

R 62 766

R 64 766

R 64 766, Risperdal, Risperidone

R 64,766

R 64766

R-118

R-64-766

R-64,766

R-64766

R0087

R64,766

R64766

RAPZEAPATHNIPO-UHFFFAOYSA-N

Relday

ripedon

RISPADAL

Rispen

Risperdal

Risperdal (TN)

Risperdal Consta

Risperdal M-Tab

risperdone

Risperidal

Risperidal M-Tab

Risperidona

Risperidona [Spanish]

Risperidone (JAN/USAN/INN)

Risperidone (JP17/USAN/INN)

Risperidone (RIS)

Risperidone (Risperdal)

Risperidone [USAN:BAN:INN]

Risperidone [USAN:USP:INN:BAN]

Risperidone 1.0 mg/ml in Methanol

Risperidone for system suitability, European Pharmacopoeia (EP) Reference Standard

Risperidone-ISM

Risperidone, >=98% (HPLC), powder

Risperidone, British Pharmacopoeia (BP) Reference Standard

Risperidone, European Pharmacopoeia (EP) Reference Standard

Risperidone, pharmaceutical secondary standard; traceable to USP, PhEur, BP

Risperidone, placebo

Risperidone, United States Pharmacopeia (USP) Reference Standard

Risperidone(R 64 766)

Risperidonum

Risperidonum [Latin]

Risperin

Rispolept

Rispolin

RTR-001241

s1615

SAM001246595

SC-16313

SCHEMBL27911

Sequinan

SMR000466323

SPBio_003078

Spiron

STK646402

TL8000230

Tox21_110253

Tox21_110253_1

TR-001241

UNII-L6UH7ZF8HC

US8802672, Risperidone

Z1522566617

ZINC538312

Tentative approvals for RISPERIDONE

Applicant	Application No.	Strength	Dosage Form
		1MG/ML	SOLUTION; ORAL

US Patents and Regulatory Information for risperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	RISPERIDONE	risperidone	TABLET;ORAL	076879-003	Oct 24, 2008	AB	RX	No	No
Renata	RISPERIDONE	risperidone	TABLET;ORAL	078707-004	Dec 29, 2008	AB	RX	No	No
Jubilant Generics	RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	090839-002	Nov 4, 2011	AB	RX	No	No
Watson Labs	RISPERIDONE	risperidone	TABLET;ORAL	077860-001	Dec 5, 2008		DISCN	No	No

Expired US Patents for risperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-001	Dec 29, 1993
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-003	Apr 2, 2003
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-003	Dec 29, 1993
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007

International Patents for risperidone

Country	Document Number	Estimated Expiration
Australia	2006299657
China	101365423
European Patent Office	2907524
European Patent Office	2152315

Supplementary Protection Certificates for risperidone

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208