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Paliperidone - Generic Drug Details
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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, Amneal Pharms, Cspc Ouyi, Inventia, Rk Pharma, and Sun Pharm, and is included in nine NDAs. There are two 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. Eleven suppliers are listed for this compound.
Summary for paliperidone
US Patents: | 2 |
Tradenames: | 4 |
Applicants: | 7 |
NDAs: | 9 |
Drug Master File Entries: | 38 |
Suppliers / Packagers: | 11 |
Bulk Api Vendors: | 123 |
Clinical Trials: | 173 |
Patent Applications: | 534 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for paliperidone |
What excipients (inactive ingredients) are in paliperidone? | paliperidone excipients list |
DailyMed Link: | paliperidone at DailyMed |
Recent Clinical Trials for paliperidone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Corcept Therapeutics | Phase 2 |
Newron Pharmaceuticals SPA | Phase 2 |
Alliance for Clinical Trials in Oncology | Phase 1 |
Pharmacology for paliperidone
Drug Class | Atypical Antipsychotic |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Inventia | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 204452-001 | Jun 12, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Sun Pharm | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 205618-003 | Apr 6, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Cspc Ouyi | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 212807-004 | Oct 29, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Cspc Ouyi | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 212807-003 | Oct 29, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Cspc Ouyi | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 212807-002 | Oct 29, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | 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 | 021999-001 | 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 | 021999-004 | Dec 19, 2006 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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