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Paliperidone - Generic Drug Details
What are the generic sources for paliperidone and what is the scope of patent protection?
Paliperidone
is the generic ingredient in four branded drugs marketed by Janssen Pharms, Actavis Labs Fl Inc, Inventia, Mylan, and Sun Pharm, and is included in seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are thirty-eight drug master file entries for paliperidone. Nine suppliers are listed for this compound.
Summary for paliperidone
| US Patents: | 3 |
| Tradenames: | 4 |
| Applicants: | 5 |
| NDAs: | 7 |
| Drug Master File Entries: | 38 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 113 |
| Clinical Trials: | 169 |
| Patent Applications: | 523 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for paliperidone |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for paliperidone |
| DailyMed Link: | paliperidone at DailyMed |
Recent Clinical Trials for paliperidone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| North District Hospital | Phase 2/Phase 3 |
| Queen Mary Hospital, Hong Kong | Phase 2/Phase 3 |
| The University of Hong Kong | Phase 2/Phase 3 |
Recent Litigation for paliperidone
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| TEVA PHARMACEUTICALS USA, INC. v. LEAVITT | 2008-03-04 |
Pharmacology for paliperidone
| Drug Class | Atypical Antipsychotic |
Synonyms for paliperidone
| (+/-)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one |
| (9RS)-3-(2-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl))ethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido(1,2-a)pyrimidin-4-one |
| (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one (9-Hydroxyrisperidone) |
| 130049-84-2 |
| 130049-86-4 |
| 144598-75-4 |
| 147687-18-1 |
| 3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-9-hydroxy-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)-9-hydroxy-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)-9-HYDROXY-2-METHYL-4H,6H,7H,8H,9H-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-9-hydroxy-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-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin4-one |
| 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-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-9-hydroxy-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-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one, 9-Hydroxyrisperidone |
| 3-[2-[4-(6-Fluoro-1,2-Benzisoxazol-3-yl)-1-Piperidinyl]Ethyl]-9-Hydroxy-6,7,8,9-Tetrahydro-2-Methyl-4H-Pyrido[1,2-a]-Pyrimidin-4-One |
| 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)-1-piperidyl]ethyl]-9-hydroxy-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]-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one |
| 3-[2-[4-(6-FLUOROBENZO[D]ISOXAZOL-3-YL)-1-PIPERIDYL]ETHYL]-7-HYDROXY-4-METHYL-1,5-DIAZABI-CYCLO[4.4.0]DECA-3,5-DIEN-2-ONE |
| 3-{2-[4-(6-fluoro-1,2-benzoisoxazol-3-yl)-1-piperidinyl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-pyrido[1,2-alpha]pyrimidin-4-one |
| 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-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}-9-hydroxy-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)piperidin-1-yl]ethyl}-9-hydroxy-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}-9-hydroxy-2-methyl-6,7,8,9- tetrahydro-pyrido[1,2-a]pyrimidin-4-one |
| 4H-Pyrido(1,2-a)pyrimidin-4-one, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8-tetrahydro-9-hydroxy-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-9-hydroxy-2-methyl- |
| 4H-Pyrido(2,1-a)pyrimidin-4-one, 6,7,8,9-tetrahydro-3-(2-(4-(6-fluro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-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-9-hydroxy-2-methyl- |
| 4H-yrido[1,2-]yrimidin-4-ne, 3-2-4-(6-luoro-1,2-enzisoxazol-3-l)-1-iperidinyl]thyl]-6,7,8,9-etrahydro-9-ydroxy-2-ethyl- |
| 598P754 |
| 6,7,8,9-Tetrahydro-3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-2-methyl-4H-pyrido[2,1-a]pyrimidin-4-one |
| 6,7,8,9-Tetrahydro-3-(2-(4-(6-fluro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-9-hydroxy-2-methyl-4H-pyrido[2,1-a]pyrimidin-4-one |
| 838F01T721 |
| 9-Hydroxy risperidone |
| 9-hydroxy risperidone |
| 9-Hydroxy Risperidone-d4 (Paliperidone D4) |
| 9-Hydroxyrisperidone |
| 9-Hydroxyrisperidone 1.0 mg/ml in Methanol |
| 9-Hydroxyrisperidone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| 9-Hydroxyrisperidone, 98% |
| 9-OH-risperidone |
| AB0018636 |
| AB1010913 |
| ABP000395 |
| AC-1282 |
| AC1L3GS8 |
| AKOS005266713 |
| AKOS016339656 |
| AKOS025392164 |
| AN-759 |
| ANW-42875 |
| AOB1667 |
| AS-13860 |
| BC228519 |
| BC677689 |
| BCP02338 |
| BCP9001047 |
| BCPP000132 |
| BDBM50252513 |
| BRD-A99888680-001-04-6 |
| C21516 |
| CCG-221866 |
| CHEBI:83804 |
| CHEMBL1621 |
| CM14424 |
| CS-0386 |
| CTK8B3649 |
| D05339 |
| DB01267 |
| FT-0080561 |
| FT-0600425 |
| GTPL7258 |
| HMS3261B06 |
| HSDB 8148 |
| HY-A0019 |
| I14-1945 |
| Invega |
| Invega (TN) |
| J10457 |
| JNS-007ER |
| KS-00000W1B |
| KS-1279 |
| L023985 |
| LP00562 |
| LS-134195 |
| MCULE-5597043685 |
| MFCD00871802 |
| MFCD09955571 |
| MLS004773953 |
| MolPort-003-848-059 |
| MolPort-020-313-413 |
| NCGC00186014-01 |
| NCGC00261247-01 |
| P1897 |
| Paliperidone (JAN/USAN/INN) |
| Paliperidone [INN] |
| Paliperidone [USAN:INN:BAN:JAN] |
| Paliperidone, >=98% (HPLC) |
| Paliperidone, United States Pharmacopeia (USP) Reference Standard |
| Paliperidone/Invega |
| PALLIPERIDONE |
| PB27526 |
| PMXMIIMHBWHSKN-UHFFFAOYSA-N |
| Q-101425 |
| Q-4343 |
| R 76477 |
| R-76477 |
| RAC 9-HYDROXY RISPERIDONE |
| RL01805 |
| RO-76477 |
| RO76477 |
| RTC-030009 |
| s1724 |
| S451 |
| SC-08807 |
| SCHEMBL436689 |
| SMR001456280 |
| SR-02000000862 |
| SR-02000000862-3 |
| ST24030055 |
| TC-030009 |
| Tox21_500562 |
| UNII-838F01T721 |
| YF10040 |
US Patents and Regulatory Information for paliperidone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-004 | Jul 31, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-001 | Jul 31, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-001 | Dec 19, 2006 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sun Pharm | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 205618-001 | Apr 6, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-003 | Jul 31, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-002 | Jul 31, 2009 | RX | Yes | 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 |
Expired US Patents for paliperidone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-006 | Aug 26, 2008 | Start Trial | Start Trial |
| Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-003 | Dec 19, 2006 | Start Trial | Start Trial |
| Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-002 | Dec 19, 2006 | Start Trial | Start Trial |
| Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-001 | Dec 19, 2006 | Start Trial | Start Trial |
| Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-004 | Dec 19, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.