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, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, Zydus Pharms, and Teva Pharms Usa. and is included in twelve 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Paliperidone
A generic version of PALIPERIDONE was approved as paliperidone palmitate by TEVA PHARMS USA on July 6th, 2021.
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Questions you can ask:
- What is the 5 year forecast for PALIPERIDONE?
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- What is Average Wholesale Price for PALIPERIDONE?
Summary for PALIPERIDONE
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 184 |
| Patent Applications: | 1,830 |
| 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 |
|---|---|
| Instituto de Salud Carlos III | Phase 4 |
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | Phase 4 |
| First Affiliated Hospital Xi'an Jiaotong University | N/A |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 217445-001 | Oct 8, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 208643-004 | Jun 29, 2022 | BX | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | PALIPERIDONE PALMITATE | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 211149-005 | Jul 6, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | PALIPERIDONE PALMITATE | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 211149-001 | Jul 6, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Inventia | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 204452-004 | Jun 12, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rk Pharma | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 203802-001 | Sep 24, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | PALIPERIDONE | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 208643-001 | Jun 29, 2022 | BX | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | |
| Janssen-Cilag International NV | Invega | paliperidone | EMEA/H/C/000746 Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.Invega is indicated for the treatment of schizoaffective disorder in adults. |
Authorised | no | no | no | 2007-06-24 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
