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-nine patent family members in twenty-six 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 three 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: | 49 |
| 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-004 | May 18, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-003 | May 18, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | 207946-002 | May 18, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-001 | May 18, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-004 | May 18, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-003 | May 18, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Patent: 20239611
Estimated Expiration: ⤷ Sign Up
Patent: 22221405
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017021383
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 25908
Estimated Expiration: ⤷ Sign Up
Patent: 88401
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0201027
Estimated Expiration: ⤷ Sign Up
Patent: 0240022
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 23203
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 80416
Estimated Expiration: ⤷ Sign Up
Patent: 44326
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 7185
Estimated Expiration: ⤷ Sign Up
Patent: 1792209
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 80416
Estimated Expiration: ⤷ Sign Up
Patent: 44326
Estimated Expiration: ⤷ Sign Up
Patent: 49323
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 44326
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 49047
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 49485
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4669
Estimated Expiration: ⤷ Sign Up
Patent: 9340
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 28221
Estimated Expiration: ⤷ Sign Up
Patent: 28503
Estimated Expiration: ⤷ Sign Up
Patent: 22277
Estimated Expiration: ⤷ Sign Up
Patent: 18510894
Estimated Expiration: ⤷ Sign Up
Patent: 20090498
Estimated Expiration: ⤷ Sign Up
Patent: 21130680
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 80416
Estimated Expiration: ⤷ Sign Up
Patent: 44326
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 80416
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 917
Estimated Expiration: ⤷ Sign Up
Patent: 511
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5952
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 80416
Estimated Expiration: ⤷ Sign Up
Patent: 44326
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 80416
Estimated Expiration: ⤷ Sign Up
Patent: 44326
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 510
Estimated Expiration: ⤷ Sign Up
Patent: 024
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 80416
Estimated Expiration: ⤷ Sign Up
Patent: 44326
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2606678
Estimated Expiration: ⤷ Sign Up
Patent: 170134583
Estimated Expiration: ⤷ Sign Up
Patent: 230162162
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 02299
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 94825
Estimated Expiration: ⤷ Sign Up
Patent: 1642863
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 8732
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Japan | 2020090498 | 長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS) | ⤷ Sign Up |
| South Korea | 102606678 | ⤷ Sign Up | |
| Morocco | 53511 | SCHÉMA DE TRAITEMENT EN CAS DE DOSES OUBLIÉES POUR DES ESTERS DE PALIPÉRIDONE INJECTABLES À ACTION PROLONGÉE | ⤷ Sign Up |
| 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 | ⤷ Sign Up |
| Japan | 2023551007 | パルミチン酸パリペリドン製剤の再懸濁を確実にする方法 | ⤷ Sign Up |
| Denmark | 3280416 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INVEGA TRINZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0904081 | C00904081/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215 |
| 0904081 | 1190023-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304 |
| 0904081 | 91842 | Luxembourg | ⤷ Sign Up | 91842, EXPIRES: 20220512 |
| 0904081 | 416 | Finland | ⤷ Sign Up | |
| 0904081 | 11C0035 | France | ⤷ Sign Up | PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304 |
| 0904081 | PA2011008,C0904081 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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