Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Dow
Mallinckrodt
Colorcon
Express Scripts

Last Updated: September 27, 2022

INVEGA SUSTENNA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 thirty-six patent family members in twenty-six 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.

DrugPatentWatch® Generic Entry Outlook for Invega Sustenna

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

There have been seven 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

< Available with Subscription >

  Try it Free

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

See drug prices for INVEGA SUSTENNA

Recent Clinical Trials for INVEGA SUSTENNA

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

SponsorPhase
Alliance for Clinical Trials in OncologyPhase 1
Evolution Research GroupPhase 1
Luye Pharma Group Ltd.Phase 1

See all INVEGA SUSTENNA clinical trials

Pharmacology for INVEGA SUSTENNA
Anatomical Therapeutic Chemical (ATC) Classes for INVEGA SUSTENNA
Paragraph IV (Patent) Challenges for INVEGA SUSTENNA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INVEGA SUSTENNA Extended-release Injectable Suspension paliperidone palmitate 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL 022264 1 2017-11-21

US Patents and Regulatory Information for INVEGA SUSTENNA

INVEGA SUSTENNA is protected by four US patents.

Patents protecting INVEGA SUSTENNA

Dosing regimen associated with long acting injectable paliperidone esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS

Dosing regimen associated with long acting injectable paliperidone esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Dosing regimen associated with long acting injectable paliperidone esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)

Dosing regimen associated with long acting injectable paliperidone esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 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 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 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for INVEGA SUSTENNA

See the table below for patents covering INVEGA SUSTENNA around the world.

Country Patent Number Title Estimated Expiration
Portugal 1033987 See Plans and Pricing
Eurasian Patent Organization 201070757 РЕЖИМ ДОЗИРОВАНИЯ ИНЪЕКЦИОННЫХ ПРЕПАРАТОВ ЭФИРОВ ПАЛИПЕРИДОНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ See Plans and Pricing
Bulgaria 62684 See Plans and Pricing
Croatia P20000289 VODENE SUSPENZIJE SUBMIKRONSKIH ESTERA MASNIH KISELINA 9-HIDROKSIRISPERIDONA (AQUEOUS SUSPENSIONS OF SUBMICRON 9-HYDROXYRISPERIDONE FATTY ACID ESTERS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INVEGA SUSTENNA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0368388 07C0044 France See Plans and Pricing PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
0904081 1190023-0 Sweden See Plans and Pricing PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081 2011/021 Ireland See Plans and Pricing PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0904081 C300491 Netherlands See Plans and Pricing PRODUCT NAME: PALIPERIDONPALMITAAT; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Merck
Harvard Business School
Moodys
Express Scripts

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.