Invega Trinza is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2015 to 2018. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 05, 2036. Details of Invega Trinza's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10143693 | Dosing regimen for missed doses for long-acting injectable paliperidone esters |
Apr, 2036
(11 years from now) | Active |
|
US6077843 (Pediatric) | Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters |
Nov, 2017
(7 years ago) |
Expired
|
| US6077843 | Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters |
May, 2017
(7 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Invega Trinza's patents.
Latest Legal Activities on Invega Trinza's Patents
Given below is the list of recent legal activities going on the following patents of Invega Trinza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 May, 2022 | US10143693 |
| Mail O.P. Petition Decision | 09 Oct, 2020 | US10143693 |
| Email Notification Critical | 09 Oct, 2020 | US10143693 |
| Mail-Petition Decision - Dismissed Critical | 07 Oct, 2020 | US10143693 |
| O.P. Petition Decision | 06 Oct, 2020 | US10143693 |
| Petition Decision - Dismissed Critical | 06 Oct, 2020 | US10143693 |
| Petition Entered | 21 Sep, 2020 | US10143693 |
| Mail Pub Notice re 312 amendment | 15 Feb, 2019 | US10143693 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 12 Feb, 2019 | US10143693 |
| Post Issue Communication - Certificate of Correction | 12 Feb, 2019 | US10143693 |
FDA has granted several exclusivities to Invega Trinza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Invega Trinza, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Invega Trinza.
Exclusivity Information
Invega Trinza holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Invega Trinza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 18, 2018 |
Several oppositions have been filed on Invega Trinza's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Invega Trinza's generic, the next section provides detailed information on ongoing and past EP oppositions related to Invega Trinza patents.
Invega Trinza's Oppositions Filed in EPO
Invega Trinza has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 01, 2020, by Instone, Terry/Read, Howard Graham/Appleyard Lees Ip Llp. This opposition was filed on patent number EP16777058A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16777058A | Jan, 2021 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP16777058A | Jan, 2021 | Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB | Granted and Under Opposition |
| EP16777058A | Jan, 2021 | df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte ParG mbB | Granted and Under Opposition |
| EP16777058A | Jan, 2021 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP16777058A | Jan, 2021 | Hexal AG | Granted and Under Opposition |
| EP16777058A | Jan, 2021 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP16777058A | Jan, 2021 | Hamm&Wittkopp Patentanwälte PartmbB | Granted and Under Opposition |
| EP16777058A | Dec, 2020 | Instone, Terry/Read, Howard Graham/Appleyard Lees IP LLP | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Invega Trinza is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Invega Trinza's family patents as well as insights into ongoing legal events on those patents.
Invega Trinza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Invega Trinza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 05, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Invega Trinza Generic API suppliers:
Paliperidone Palmitate is the generic name for the brand Invega Trinza. 1 company has already filed for the generic of Invega Trinza. Check out the entire list of companies who have already received approval for Invega Trinza's generic
How can I launch a generic of Invega Trinza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Invega Trinza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Invega Trinza's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Invega Trinza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 546 mg/1.75 mL | 24 Jun, 2020 | 1 | 05 Apr, 2036 | ||
| 819 mg/2.625 mL | 30 Apr, 2021 | 1 | 05 Apr, 2036 | ||
| 273 mg/0.875 mL and 410 mg/1.315 mL | 14 Jul, 2021 | 1 | 05 Apr, 2036 |
Alternative Brands for Invega Trinza
Invega Trinza which is used for managing symptoms of schizophrenia in patients who have missed doses or need to restart treatment., has several other brand drugs in the same treatment category and using the same active ingredient (Paliperidone Palmitate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Alkermes Inc |
| |||||||||
| Indivior |
| |||||||||
| Intra-cellular |
| |||||||||
| Janssen Pharms |
| |||||||||
| Otsuka |
| |||||||||
| Otsuka Pharm Co Ltd |
| |||||||||
| Sunovion Pharms Inc |
| |||||||||
| Teva |
| |||||||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Paliperidone Palmitate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Janssen Pharms |
| |
| Luye Innomind Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Paliperidone Palmitate, Invega Trinza's active ingredient. Check the complete list of approved generic manufacturers for Invega Trinza
About Invega Trinza
Invega Trinza is a drug owned by Janssen Pharmaceuticals Inc. It is used for managing symptoms of schizophrenia in patients who have missed doses or need to restart treatment. Invega Trinza uses Paliperidone Palmitate as an active ingredient. Invega Trinza was launched by Janssen Pharms in 2021.
Approval Date:
Invega Trinza was approved by FDA for market use on 30 August, 2021.
Active Ingredient:
Invega Trinza uses Paliperidone Palmitate as the active ingredient. Check out other Drugs and Companies using Paliperidone Palmitate ingredient
Treatment:
Invega Trinza is used for managing symptoms of schizophrenia in patients who have missed doses or need to restart treatment.
Dosage:
Invega Trinza is available in suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 819MG/2.625ML (312MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 546MG/1.75ML (312MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 410MG/1.315ML (311.79MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 273MG/0.875ML (273MG/0.875ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |