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Last Updated: September 25, 2022

RISPERDAL CONSTA Drug Patent Profile


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When do Risperdal Consta patents expire, and when can generic versions of Risperdal Consta launch?

Risperdal Consta is a drug marketed by Janssen Pharms and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Risperdal Consta

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

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Drug patent expirations by year for RISPERDAL CONSTA
Drug Prices for RISPERDAL CONSTA

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Recent Clinical Trials for RISPERDAL CONSTA

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SponsorPhase
Otsuka America PharmaceuticalPhase 4
Gazda, Thomas D., M.D., PCPhase 4
Zogenix, Inc.Phase 1

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Anatomical Therapeutic Chemical (ATC) Classes for RISPERDAL CONSTA

US Patents and Regulatory Information for RISPERDAL CONSTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 RX Yes 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 RISPERDAL CONSTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007 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
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 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 RISPERDAL CONSTA

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

Supplementary Protection Certificates for RISPERDAL CONSTA

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
0196132 SPC/GB93/036 United Kingdom See Plans and Pricing SPC/GB93/036:, EXPIRES: 20071207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.