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Last Updated: March 3, 2021

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INVEGA TRINZA Drug Profile

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When do Invega Trinza patents expire, and what generic alternatives are available?

Invega Trinza is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-three countries.

The generic ingredient in INVEGA TRINZA 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 Trinza

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 5, 2036. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 TRINZA
Drug Prices for INVEGA TRINZA

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Generic Entry Opportunity Date for INVEGA TRINZA
Generic Entry Date for INVEGA TRINZA*:
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.

Pharmacology for INVEGA TRINZA
Paragraph IV (Patent) Challenges for INVEGA TRINZA
Tradename Dosage Ingredient NDA Submissiondate
INVEGA TRINZA SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR paliperidone palmitate 207946 2020-06-24

US Patents and Regulatory Information for INVEGA TRINZA

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 TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-001 May 18, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015 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 TRINZA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-001 May 18, 2015   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for INVEGA TRINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0904081 1190023-0 Sweden   Start Trial PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081 C300491 Netherlands   Start Trial PRODUCT NAME: PALIPERIDONPALMITAAT; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0368388 07C0044 France   Start Trial 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 PA2011008,C0904081 Lithuania   Start Trial PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
0904081 PA2011008 Lithuania   Start Trial PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
0904081 SPC/GB11/044 United Kingdom   Start Trial PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Boehringer Ingelheim
Express Scripts
AstraZeneca
Merck

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