You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 21, 2024

RISPERIDONE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Risperidone is the generic ingredient in seven branded drugs marketed by Labs Farms Rovi Sa, Shandong Luye, Indivior, Janssen Pharms, 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, Teva, 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, Celltrion, Heritage Pharma Avet, Jubilant Cadista, 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 fifty-three NDAs. There are twenty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has one hundred and forty-nine patent family members in thirty-nine countries.

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

Drug Prices for RISPERIDONE

See drug prices for RISPERIDONE

Drug Sales Revenue Trends for RISPERIDONE

See drug sales revenues for RISPERIDONE

Recent Clinical Trials for RISPERIDONE

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

SponsorPhase
Consorcio Centro de Investigación Biomédica en Red (CIBER)Phase 4
Instituto de Salud Carlos IIIPhase 4
First Affiliated Hospital Xi'an Jiaotong UniversityN/A

See all RISPERIDONE clinical trials

Generic filers with tentative approvals for RISPERIDONE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up1MG/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
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
Torrent Pharms RISPERIDONE risperidone TABLET;ORAL 079088-002 Oct 30, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal RISPERIDONE risperidone TABLET;ORAL 078071-004 Jun 17, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva UZEDY risperidone SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 213586-005 Apr 28, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Dr Reddys Labs Ltd RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077328-005 Nov 30, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Renata RISPERIDONE risperidone TABLET;ORAL 078707-005 Dec 29, 2008 AB RX 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

Expired US Patents for RISPERIDONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ⤷  Sign Up ⤷  Sign Up
>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
Cuba 20130091 COMPOSICIONES DE SUMINISTRO DE FÁRMACOS BIODEGRADABLES ⤷  Sign Up
Eurasian Patent Organization 027046 БИОРАЗЛАГАЕМАЯ КОМПОЗИЦИЯ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ЕЕ ПРИМЕНЕНИЕ (BIODEGRADABLE DRUG DELIVERY COMPOSITION, METHOD FOR PREPARING SAME AND USE THEREOF) ⤷  Sign Up
European Patent Office 2152315 FORMULATIONS D'ADMINISTRATION PROLONGÉE DE COMPOSÉS DE RISPÉRIDONE (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS) ⤷  Sign Up
European Patent Office 1909689 IMPLANTS CONTENANT UN MEDICAMENT ET LEUR PROCEDE D'UTILISATION (DRUG-CONTAINING IMPLANTS AND METHODS OF USE THEREOF) ⤷  Sign Up
Taiwan 200803920 Sustained release small molecule drug formulation ⤷  Sign Up
>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 ⤷  Sign Up 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

Make Better Decisions: Try a trial or see plans & pricing

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.