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RISPERIDONE Drug Profile

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When do Risperidone patents expire, and when can generic versions of Risperidone launch?

Risperidone is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Precision Dose, Taro, Torrent, Tris Pharma Inc, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Celltrion, Ceyone, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, 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-four NDAs.

The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the risperidone profile page.

Summary for RISPERIDONE

US Patents:	0
Applicants:	36
NDAs:	44
Suppliers / Packagers:	41
Bulk Api Vendors:	115
Clinical Trials:	490
Patent Applications:	5,668
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RISPERIDONE
Drug Sales Revenues:	Drug sales revenues for RISPERIDONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RISPERIDONE
DailyMed Link:	RISPERIDONE at DailyMed

See drug prices for RISPERIDONE

See drug sales revenues for RISPERIDONE

Recent Clinical Trials for RISPERIDONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indivior Inc.	Phase 4
Oregon Health and Science University	Phase 4
Sadat City University	Phase 1/Phase 2

See all RISPERIDONE clinical trials

Recent Litigation for RISPERIDONE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd.	2019-07-17
United States v. Indivior Inc.	2019-04-09
Purdue Pharmaceutical v. Actavis Elizabeth LLC	2015-05-13

See all RISPERIDONE litigation

PTAB Litigation

Petitioner	Date
Luye Pharma Group Ltd.	2016-05-31

See all RISPERIDONE litigation

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

1026102-43-1

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]?-?2,?3,?6,?7,?8,?9-?hexahydro-?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-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-fluoranyl-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-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)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-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

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

AKOS005577302

AN-15065

ANW-42874

Apexidone

API0004081

BC206675

BCP08161

BDBM50001885

Belivon

BG0309

BIDD:GT0262

BRD-K53857191-001-04-5

BRD-K53857191-001-10-2

BRN 4891881

C-21900

C23H27FN4O2

CAS-106266-06-2

CC-34268

CCG-100930

CHEBI:8871

CHEMBL85

CPD000466323

CR0023

CS-1619

D00426

DB00734

DSSTox_CID_25193

DSSTox_GSID_45193

DSSTox_RID_80740

DTXSID8045193

EU-0101074

FT-0631037

GTPL96

HMS1571M19

HMS2051H07

HMS2089C22

HMS2098M19

HMS2233O11

HMS3373M18

HMS3393H07

HMS3657G13

HMS3715M19

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

R 64766

R-118

R-64-766

R-64766

R0087

RAPZEAPATHNIPO-UHFFFAOYSA-N

Relday

Rispen

Risperdal

Risperdal (TN)

Risperdal Consta

Risperdal M-Tab

risperdone

Risperidal

Risperidal M-Tab

Risperidona

Risperidona [Spanish]

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 solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

Risperidone-ISM

Risperidone, >=98% (HPLC), powder

Risperidone, 99%

Risperidone, British Pharmacopoeia (BP) Reference Standard

Risperidone, European Pharmacopoeia (EP) Reference Standard

Risperidone, Pharmaceutical Secondary Standard; Certified Reference Material

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

SR-01000075399

SR-01000075399-2

SR-01000075399-8

STK646402

SW197348-4

TL8000230

Tox21_110253

Tox21_110253_1

TR-001241

UNII-L6UH7ZF8HC

US8802672, Risperidone

Z1522566617

ZINC538312

Zophrenal

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
Celltrion	RISPERIDONE	risperidone	TABLET;ORAL	078871-001	Oct 9, 2008	AB	RX	No	No
Heritage Pharma	RISPERIDONE	risperidone	TABLET;ORAL	077769-003	Oct 16, 2008	AB	RX	No	No
Par Pharm	RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	077494-005	Apr 30, 2009	AB	RX	No	No
Mylan Pharms Inc	RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	091537-001	Mar 30, 2011		DISCN	No	No
Watson Labs	RISPERIDONE	risperidone	TABLET;ORAL	077860-001	Dec 5, 2008		DISCN	No	No