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Last Updated: December 3, 2022

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 six branded drugs marketed by Janssen Pharms, Actavis Labs Fl Inc, Amneal Pharms, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, and Teva Pharms Usa, and is included in eleven NDAs. There are four 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. Thirteen suppliers are listed for this compound.

Drug Prices for paliperidone

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Recent Clinical Trials for paliperidone

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SponsorPhase
Janssen-Cilag International NVPhase 4
Corcept TherapeuticsPhase 2
Newron Pharmaceuticals SPAPhase 2

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Pharmacology 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
Rk Pharma PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 203802-003 Sep 24, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-004 Dec 19, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 205618-002 Apr 6, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-003 Dec 19, 2006 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-004 Dec 19, 2006 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-002 Dec 19, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

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