PALIPERIDONE Drug Patent Profile
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When do Paliperidone patents expire, and when can generic versions of Paliperidone launch?
Paliperidone is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, and Teva Pharms Usa. and is included in nine NDAs.
The generic ingredient in PALIPERIDONE is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for PALIPERIDONE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 183 |
| Patent Applications: | 2,188 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | N/A |
| Janssen-Cilag International NV | Phase 4 |
| Corcept Therapeutics | Phase 2 |
Pharmacology for PALIPERIDONE
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for PALIPERIDONE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 205618-004 | Apr 6, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rk Pharma | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 203802-004 | Sep 24, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | PALIPERIDONE PALMITATE | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 211149-001 | Jul 6, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for PALIPERIDONE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen-Cilag International N.V. | Byannli (previously Paliperidone Janssen-Cilag International) | paliperidone | EMEA/H/C/005486 Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1). |
Authorised | no | no | no | 2020-06-18 | |
| Janssen-Cilag International NV | Trevicta (previously Paliperidone Janssen) | paliperidone | EMEA/H/C/004066 Trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product. |
Authorised | no | no | no | 2014-12-05 | |
| Janssen-Cilag International N.V. | Xeplion | paliperidone | EMEA/H/C/002105 Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. |
Authorised | no | no | no | 2011-03-04 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
