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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Deloitte
Johnson and Johnson
Healthtrust
Federal Trade Commission
Fuji
Cipla
Mallinckrodt
Fish and Richardson

Generated: August 18, 2018

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RISPERIDONE - Generic Drug Details

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

Risperidone is the generic ingredient in three branded drugs marketed by 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-eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has sixty-two patent family members in twenty-six countries.

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.

Pharmacology for RISPERIDONE
Medical Subject Heading (MeSH) Categories for RISPERIDONE
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
➤ Sign Up➤ Sign Up1MG/MLSOLUTION; 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
Sun Pharm Inds Ltd RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 078474-001 Aug 6, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc RISPERIDONE risperidone SOLUTION;ORAL 077719-001 Jul 29, 2009 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Jubilant Generics RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 090839-004 Nov 4, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs RISPERIDONE risperidone TABLET;ORAL 077860-004 Dec 5, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Prinston Inc RISPERIDONE risperidone TABLET;ORAL 077493-005 Nov 29, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ajanta Pharma Ltd RISPERIDONE risperidone TABLET;ORAL 201003-004 Aug 24, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ratiopharm RISPERIDONE risperidone TABLET;ORAL 077784-005 Jun 8, 2010 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for RISPERIDONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-001 Apr 2, 2003 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-005 Dec 29, 1993 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for RISPERIDONE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,852,638 Sustained release small molecule drug formulation ➤ Sign Up
9,044,450 Sustained release small molecule drug formulation ➤ Sign Up
6,495,164 Preparation of injectable suspensions having improved injectability ➤ Sign Up
7,371,406 Preparation of injectable suspensions having improved injectability ➤ Sign Up
7,799,345 Preparation of injectable suspensions having improved injectability ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for RISPERIDONE

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

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