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Last Updated: October 23, 2020

DrugPatentWatch Database Preview

INVEGA SUSTENNA Drug Profile

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Which patents cover Invega Sustenna, and when can generic versions of Invega Sustenna launch?

Invega Sustenna is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in seventeen countries.

The generic ingredient in INVEGA SUSTENNA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

US ANDA Litigation and Generic Entry Outlook for Invega Sustenna

Invega Sustenna was eligible for patent challenges on December 19, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 26, 2031. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for INVEGA SUSTENNA
Drug Prices for INVEGA SUSTENNA

See drug prices for INVEGA SUSTENNA

Generic Entry Opportunity Date for INVEGA SUSTENNA
Generic Entry Date for INVEGA SUSTENNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INVEGA SUSTENNA

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

SponsorPhase
Luye Pharma Group Ltd.Phase 1
Alkermes, Inc.Phase 3
Otsuka America PharmaceuticalPhase 4

See all INVEGA SUSTENNA clinical trials

Pharmacology for INVEGA SUSTENNA
Paragraph IV (Patent) Challenges for INVEGA SUSTENNA
Tradename Dosage Ingredient NDA Submissiondate
INVEGA SUSTENNA SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR paliperidone palmitate 022264 2017-11-21

US Patents and Regulatory Information for INVEGA SUSTENNA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 RX Yes No   Start Trial   Start Trial   Start 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 INVEGA SUSTENNA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009   Start Trial   Start Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for INVEGA SUSTENNA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0904081 PA2011008 Lithuania   Start Trial PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
0904081 CA 2011 00020 Denmark   Start Trial
0368388 91362 Luxembourg   Start Trial 91362, EXPIRES: 20141030
0904081 11C0035 France   Start Trial PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
0368388 C300298 Netherlands   Start Trial PRODUCT NAME: PALIPERIDON, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIE ZOUT; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0904081 PA2011008,C0904081 Lithuania   Start Trial PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
0904081 91842 Luxembourg   Start Trial 91842, EXPIRES: 20220512
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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