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Last Updated: December 3, 2022

Risperidone - Generic Drug Details


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What are the generic drug sources for risperidone and what is the scope of freedom to operate?

Risperidone is the generic ingredient in four branded drugs marketed by Indivior Inc, Janssen Pharms, Amneal Pharms, Ani Pharms, Atlantide, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma Avet, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, 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-nine NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has thirty-eight patent family members in seventeen countries.

There are thirty drug master file entries for risperidone. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for risperidone

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Drug Sales Revenue Trends for risperidone

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Recent Clinical Trials for risperidone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of MinhoPhase 2
Clinical Academic Center (2CA-Braga)Phase 2
University of GeorgiaPhase 4

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Generic filers with tentative approvals for RISPERIDONE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1MG/MLSOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for risperidone
Medical Subject Heading (MeSH) Categories 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
Watson Labs RISPERIDONE risperidone TABLET;ORAL 077860-004 Dec 5, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan RISPERIDONE risperidone TABLET;ORAL 076288-003 Sep 15, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms Usa Inc RISPERIDONE risperidone TABLET;ORAL 078040-003 Oct 16, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Pharms Inc RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 091537-006 Feb 12, 2013 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Synthon Pharms RISPERIDONE risperidone TABLET;ORAL 078187-002 Oct 22, 2009 DISCN 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 risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 See Plans and Pricing See Plans and Pricing
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-008 May 10, 1999 See Plans and Pricing See Plans and Pricing
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-002 Apr 2, 2003 See Plans and Pricing See Plans and Pricing
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 See Plans and Pricing See Plans and Pricing
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 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 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

International Patents for risperidone

Country Patent Number Title Estimated Expiration
Canada 2624088 FORMULATION DE MEDICAMENTS A PETITES MOLECULES A LIBERATION PROLONGEE (SUSTAINED RELEASE SMALL MOLECULE DRUG FORMULATION) See Plans and Pricing
Mexico 2009012781 FORMULACIONES DE TRANSFERENCIA SOSTENIDA DE COMPUESTOS DE RISPERIDONA. (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS.) See Plans and Pricing
Japan 2014240436 リスペリドン化合物の徐放送達製剤 (SUSTAINED RELEASE DELIVERY FORMULATION OF RISPERIDONE COMPOUND) See Plans and Pricing
Japan 2010531807 See Plans and Pricing
Mexico 354603 FORMULACIONES DE TRANSFERENCIA SOSTENIDA DE COMPUESTOS DE RISPERIDONA. (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for risperidone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0196132 94C0008 Belgium See Plans and Pricing PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.