INVEGA TRINZA Drug Patent 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 and three Paragraph IV challenges.
This drug has forty patent family members in twenty-five 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 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.
There are two tentative approvals for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for INVEGA TRINZA
International Patents: | 40 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 50 |
Patent Applications: | 169 |
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 |
Pharmacology for INVEGA TRINZA
Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for INVEGA TRINZA
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
Dosing regimen for missed doses for long-acting injectable paliperidone esters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
Dosing regimen for missed doses for long-acting injectable paliperidone esters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-004 | May 18, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-003 | May 18, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | 207946-003 | May 18, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-001 | May 18, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-004 | May 18, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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
Patent: 16244801
Estimated Expiration: ⤷ Try a Trial
Patent: 20239611
Estimated Expiration: ⤷ Try a Trial
Patent: 22221405
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017021383
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 25908
Estimated Expiration: ⤷ Try a Trial
Patent: 88401
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0201027
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 23203
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 80416
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 7185
Estimated Expiration: ⤷ Try a Trial
Patent: 1792209
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 80416
Estimated Expiration: ⤷ Try a Trial
Patent: 44326
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 49047
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 49485
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4669
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 28221
Estimated Expiration: ⤷ Try a Trial
Patent: 28503
Estimated Expiration: ⤷ Try a Trial
Patent: 22277
Estimated Expiration: ⤷ Try a Trial
Patent: 18510894
Estimated Expiration: ⤷ Try a Trial
Patent: 20090498
Estimated Expiration: ⤷ Try a Trial
Patent: 21130680
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 80416
Estimated Expiration: ⤷ Try a Trial
Patent: 44326
Estimated Expiration: ⤷ Try a Trial
Moldova, Republic of
Patent: 80416
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 917
Estimated Expiration: ⤷ Try a Trial
Patent: 511
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 5952
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 80416
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 80416
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 510
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 80416
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2606678
Estimated Expiration: ⤷ Try a Trial
Patent: 170134583
Estimated Expiration: ⤷ Try a Trial
Patent: 230162162
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 02299
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 94825
Estimated Expiration: ⤷ Try a Trial
Patent: 1642863
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 8732
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Norway | 315931 | ⤷ Try a Trial | |
Lithuania | 3744326 | ⤷ Try a Trial | |
Japan | 2023552329 | 持続放出パリペリドン注射可能製剤に関連する投与レジメン | ⤷ Try a Trial |
Cyprus | 2270 | Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters | ⤷ Try a Trial |
Australia | 2020239611 | Dosing regimen for missed doses for long-acting injectable paliperidone esters | ⤷ Try a Trial |
New Zealand | 735952 | Dosing regimen for missed doses for long-acting injectable paliperidone esters | ⤷ Try a Trial |
Malaysia | 126302 | AQUEOUS SUSPENSIONS OF 9-HYDROXYRISPERIDONE FATTY ACID ESTERS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INVEGA TRINZA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0904081 | C300491 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONPALMITAAT; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304 |
0904081 | SPC/GB11/044 | United Kingdom | ⤷ Try a 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 |
0904081 | 1190023-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304 |
0904081 | C00904081/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215 |
0368388 | SPC/GB07/065 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021 |
0904081 | PA2011008 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304 |
0904081 | 416 | Finland | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |