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Last Updated: March 28, 2024

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

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Drug patent expirations by year for INVEGA
Drug Prices for INVEGA

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Recent Clinical Trials for INVEGA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Evolution Research GroupPhase 1
Alliance for Clinical Trials in OncologyPhase 1
Luye Pharma Group Ltd.Phase 1

See all INVEGA clinical trials

Pharmacology for INVEGA
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
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-006 Aug 30, 2021 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
>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 021999-006 Aug 26, 2008 ⤷  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
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 021999-003 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
>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
Japan H02191276 NOVEL 3-PIPERIDINYL-1,2-BENZISOXAZOLE ⤷  Try a Trial
Luxembourg 91362 ⤷  Try a Trial
Ireland 893564 ⤷  Try a Trial
Chile 43432 PROCEDIMIENTO DE PREPARACION DE 1,2-BENZISOXAZOL-3-IL-4-PIPERIDINIL-ALQUIL-6,7,8,9-TETRAHIDRO-PIRIDO[1,2a]PIRIMIDIN-4-ONA. ⤷  Try a Trial
Hong Kong 131696 3-piperidinyl-1,2-benzisoxazoles ⤷  Try a Trial
Norway 2007017 ⤷  Try a Trial
South Africa 8908436 ⤷  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
0904081 11C0035 France ⤷  Try a Trial PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
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 07C0044 France ⤷  Try a Trial PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
0368388 78/2007 Austria ⤷  Try a Trial PRODUCT NAME: PALIPERIDON, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0904081 2011/021 Ireland ⤷  Try a Trial PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
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
0368388 C300298 Netherlands ⤷  Try a Trial PRODUCT NAME: PALIPERIDON, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIE ZOUT; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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