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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 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 eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Risperidone has ninety-nine patent family members in twenty-eight 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.
Summary for risperidone
| International Patents: | 99 |
| US Patents: | 8 |
| Tradenames: | 4 |
| Applicants: | 38 |
| NDAs: | 49 |
| Drug Master File Entries: | 30 |
| Suppliers / Packagers: | 56 |
| Bulk Api Vendors: | 98 |
| Clinical Trials: | 472 |
| Patent Applications: | 6,626 |
| 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
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 |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Jubilant Generics | RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 090839-003 | Nov 4, 2011 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Dr Reddys Labs Ltd | RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077328-001 | Feb 24, 2009 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Renata | RISPERIDONE | risperidone | TABLET;ORAL | 078707-006 | Dec 29, 2008 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-004 | Apr 12, 2007 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| 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 | risperidone | TABLET;ORAL | 020272-004 | Dec 29, 1993 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-004 | Apr 12, 2007 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-002 | Oct 29, 2003 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-005 | Dec 29, 1993 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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 | ➤ Try a Free Trial |
| 9,044,450 | Sustained release small molecule drug formulation | ➤ Try a Free Trial |
| 6,495,164 | Preparation of injectable suspensions having improved injectability | ➤ Try a Free Trial |
| 7,371,406 | Preparation of injectable suspensions having improved injectability | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
see a sample report or, see our see our flat-rate plans
International Patents for risperidone
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1143731 | ➤ Try a Free Trial |
| Japan | 4694694 | ➤ Try a Free Trial |
| New Zealand | 581862 | ➤ Try a Free Trial |
| World Intellectual Property Organization (WIPO) | 2007041410 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for risperidone
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0008 | Belgium | ➤ Try a Free Trial | 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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