INVEGA TRINZA Drug Patent Profile

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 and three Paragraph IV challenges.

This drug has thirty-two patent family members in twenty-four 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.

DrugPatentWatch^® Generic Entry Outlook for Invega Trinza

There have been three 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

Summary for INVEGA TRINZA

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Patent Applications:	189
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for INVEGA TRINZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVEGA TRINZA
What excipients (inactive ingredients) are in INVEGA TRINZA?	INVEGA TRINZA excipients list
DailyMed Link:	INVEGA TRINZA at DailyMed

See drug prices for INVEGA TRINZA

Pharmacology for INVEGA TRINZA

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for INVEGA TRINZA

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for INVEGA TRINZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	273 mg/0.875 mL and 410 mg/1.315 mL	207946	1	2021-07-14
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	819 mg/2.625 mL	207946	1	2021-04-30
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	546 mg/1.75 mL	207946	1	2020-06-24

US Patents and Regulatory Information for INVEGA TRINZA

INVEGA TRINZA is protected by two US patents.

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

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	207946-004	May 18, 2015
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-003	May 18, 2015

International Patents for INVEGA TRINZA

When does loss-of-exclusivity occur for INVEGA TRINZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Moldova, Republic of

Morocco

New Zealand

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INVEGA TRINZA around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	327995
Hong Kong	1249047	用於長效可注射的帕利酮酯的遺漏劑量的投藥療程 (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS)
Cyprus	2270	Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters
New Zealand	330369	aqueous medicaments containing 9-hydroxy-risperidone fatty acid ester

Supplementary Protection Certificates for INVEGA TRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	1190023-0	Sweden		PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081	CA 2011 00020	Denmark
0904081	SPC/GB11/044	United Kingdom		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
0904081	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304