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Last Updated: June 24, 2021

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RISPERDAL CONSTA Drug 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-six 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

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   Try Before You Buy   Try Before You Buy   Try Before You Buy
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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   Try Before You Buy   Try Before You Buy
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003   Try Before You Buy   Try Before You Buy
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003   Try Before You Buy   Try Before You Buy
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003   Try Before You Buy   Try Before You Buy
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RISPERDAL CONSTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0196132 94C0008 Belgium   Try Before You Buy PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
0196132 SPC/GB93/036 United Kingdom   Try Before You Buy SPC/GB93/036:, EXPIRES: 20071207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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