✉ Email this page to a colleague
« Back to Dashboard
▶ Start for $1
Remove trial restrictions
Paliperidoneis 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.
Summary for paliperidone
|Drug Master File Entries:||38|
|Finished Product Suppliers / Packagers:||13|
|Raw Ingredient (Bulk) Api Vendors:||139|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends 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
|Janssen-Cilag International NV||Phase 4|
|Corcept Therapeutics||Phase 2|
|Newron Pharmaceuticals SPA||Phase 2|
Pharmacology for paliperidone
|Drug Class||Atypical Antipsychotic |
|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|
|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|
|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).
|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.
|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.
|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.
|>Company||>Drugname||>Inn||>Product Number / Indication||>Status||>Generic||>Biosimilar||>Orphan||>Marketing Authorisation||>Marketing Refusal|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.