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Last Updated: January 18, 2021

DrugPatentWatch Database Preview

RISPERIDONE Drug Profile

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

Risperidone is a drug marketed by Amneal Pharms, Ani Pharms Inc, Aurobindo Pharma Ltd, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, Chartwell Molecular, Jubilant Cadista, Mylan, 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-four NDAs.

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

US ANDA 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
University of GeorgiaPhase 4
Hartford HospitalPhase 4
University of Texas Southwestern Medical CenterPhase 4

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Pharmacology for RISPERIDONE
Medical Subject Heading (MeSH) Categories for RISPERIDONE
Paragraph IV (Patent) Challenges for RISPERIDONE
Tradename Dosage Ingredient NDA Submissiondate
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-04-11
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-03-23
RISPERDAL TABLET;ORAL risperidone 020272
RISPERDAL SOLUTION;ORAL risperidone 020588

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
Apotex Inc RISPERIDONE risperidone TABLET;ORAL 077953-001 Sep 15, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharma RISPERIDONE risperidone TABLET;ORAL 077769-003 Oct 16, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077494-005 Apr 30, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 091537-001 Mar 30, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
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Medtronic
Express Scripts
Baxter

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