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Last Updated: November 4, 2024

RISPERIDONE Drug Patent Profile


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When do Risperidone patents expire, and what generic alternatives are available?

Risperidone is a drug marketed by Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sciegen Pharms Inc, Taro, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Endo Operations, Jubilant Generics, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc. and is included in forty-six NDAs.

The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Risperidone

A generic version of RISPERIDONE was approved as risperidone by APOTEX INC on September 15th, 2008.

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Drug patent expirations by year for RISPERIDONE
Drug Prices for RISPERIDONE

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Drug Sales Revenue Trends for RISPERIDONE

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Recent Clinical Trials for RISPERIDONE

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SponsorPhase
Instituto de Salud Carlos IIIPhase 4
Assiut UniversityPhase 4
Consorcio Centro de Investigación Biomédica en Red (CIBER)Phase 4

See all RISPERIDONE clinical trials

Pharmacology for RISPERIDONE
Medical Subject Heading (MeSH) Categories for RISPERIDONE
Anatomical Therapeutic Chemical (ATC) Classes for RISPERIDONE
Paragraph IV (Patent) Challenges for RISPERIDONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RISPERDAL Orally Disintegrating Tablets risperidone 0.25 mg 021444 1 2005-04-11
RISPERDAL Orally Disintegrating Tablets risperidone 3 mg and 4 mg 021444 1 2005-03-23

US Patents and Regulatory Information for RISPERIDONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal RISPERIDONE risperidone TABLET;ORAL 078071-003 Jun 17, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Heritage Pharma Avet RISPERIDONE risperidone TABLET;ORAL 077769-001 Oct 16, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077494-006 Apr 30, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077328-002 Oct 5, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Synthon Pharms RISPERIDONE risperidone TABLET;ORAL 078187-003 Oct 22, 2009 DISCN 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 RISPERIDONE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A. Okedi risperidone EMEA/H/C/005406
Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.
Authorised no no no 2022-02-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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