DrugPatentWatch Database Preview
RISPERIDONE Drug Profile
When do Risperidone patents expire, and when can generic versions of Risperidone launch?
Risperidone is a drug marketed by Amneal Pharms, Ani Pharms Inc, Aurobindo Pharma Ltd, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, 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, Apotex Inc, Celltrion, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, Prinston Inc, Ratiopharm, Renata, Rising, 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. Thirty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.
US ANDA Litigation and Generic Entry Outlook for Risperidone
A generic version of RISPERIDONE was approved as risperidone by APOTEX INC on January 28th, 2020.
Summary for RISPERIDONE
See drug prices for RISPERIDONE
Recent Clinical Trials for RISPERIDONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Rochester | Phase 2 |
| Copenhagen University Hospital, Denmark | Phase 2 |
| University of Copenhagen | Phase 2 |
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 |
Pharmacology for RISPERIDONE
| Drug Class | Atypical Antipsychotic |
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 |
| 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 |
Paragraph IV (Patent) Challenges for RISPERIDONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RISPERDAL | TABLET, ORALLY DISINTEGRATING;ORAL | risperidone | 021444 | 2005-04-11 |
| RISPERDAL | TABLET, ORALLY DISINTEGRATING;ORAL | risperidone | 021444 | 2005-03-23 |
| RISPERDAL | SOLUTION;ORAL | risperidone | 020588 | |
| RISPERDAL | TABLET;ORAL | risperidone | 020272 |
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 | Start Trial | Start Trial | Start Trial | |||
| Heritage Pharma | RISPERIDONE | risperidone | TABLET;ORAL | 077769-006 | Oct 16, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Par Pharm | RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077494-005 | Apr 30, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
