INVEGA Drug Patent Profile
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When do Invega patents expire, and when can generic versions of Invega launch?
Invega is a drug marketed by Janssen Pharms and is included in three NDAs. There are five patents protecting this drug.
The generic ingredient in INVEGA 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® Generic Entry Outlook for Invega
Invega was eligible for patent challenges on December 19, 2010.
There are two tentative approvals for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for INVEGA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 29 |
Patent Applications: | 2,188 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for INVEGA |
What excipients (inactive ingredients) are in INVEGA? | INVEGA excipients list |
DailyMed Link: | INVEGA at DailyMed |
Recent Clinical Trials for INVEGA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Evolution Research Group | Phase 1 |
Alliance for Clinical Trials in Oncology | Phase 1 |
Luye Pharma Group Ltd. | Phase 1 |
Pharmacology for INVEGA
Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for INVEGA
US Patents and Regulatory Information for INVEGA
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 | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-006 | Aug 26, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-002 | Jul 31, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | INVEGA HAFYERA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-005 | Aug 30, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-003 | Dec 19, 2006 | AB | RX | Yes | 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 |
Expired US Patents for INVEGA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-004 | Dec 19, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-002 | Dec 19, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-006 | Aug 26, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-003 | Dec 19, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA | paliperidone | TABLET, EXTENDED RELEASE;ORAL | 021999-001 | Dec 19, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for INVEGA
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 |
International Patents for INVEGA
See the table below for patents covering INVEGA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 68922577 | ⤷ Try a Trial | |
Australia | 614437 | ⤷ Try a Trial | |
Japan | 2758045 | ⤷ Try a Trial | |
Finland | 92201 | ⤷ Try a Trial | |
Norway | 2007017 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INVEGA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0368388 | SPC/GB07/065 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021 |
0368388 | 91362 | Luxembourg | ⤷ Try a Trial | 91362, EXPIRES: 20141030 |
0904081 | SPC/GB11/044 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304 |
0904081 | 2011/021 | Ireland | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304 |
0904081 | 11C0035 | France | ⤷ Try a Trial | PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |