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Last Updated: March 19, 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, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Jubilant Generics, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, Heritage Pharma Avet, Jubilant Cadista, Prinston Inc, Ratiopharm, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, Westminster Pharms, and Zydus Pharms Usa Inc. and is included in forty-five 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
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Drug Sales Revenue Trends for RISPERIDONE

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Recent Clinical Trials for RISPERIDONE

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SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
All India Institute of Medical Sciences, BhubaneswarN/A
University of New MexicoPhase 4

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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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd RISPERIDONE risperidone TABLET;ORAL 076879-002 Oct 24, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077494-001 Apr 30, 2009 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077328-002 Oct 5, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs RISPERIDONE risperidone TABLET;ORAL 077860-003 Dec 5, 2008 DISCN No 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

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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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.