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Last Updated: March 28, 2024

RISPERDAL CONSTA Drug Patent Profile


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Which patents cover Risperdal Consta, and what generic alternatives are available?

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-seven 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

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

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

See all RISPERDAL CONSTA clinical trials

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 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 AB RX Yes 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

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 021346-003 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
0196132 SPC/GB93/036 United Kingdom ⤷  Try a Trial SPC/GB93/036:, EXPIRES: 20071207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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