Invega Hafyera is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2022 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 24, 2041. Details of Invega Hafyera'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). | |||
| US11666697 | Methods for ensuring resuspension of paliperidone palmitate formulations |
Nov, 2041
(16 years from now) | Active |
| US11304951 | Dosing regimens associated with extended release paliperidone injectable formulations |
May, 2041
(15 years from now) | Active |
| US12208100 | Dosing regimens associated with extended release paliperidone injectable formulations |
May, 2041
(15 years from now) | Active |
| US11324751 | Dosing regimens associated with extended release paliperidone injectable formulations |
May, 2041
(15 years from now) | Active |
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 Hafyera's patents.
Latest Legal Activities on Invega Hafyera's Patents
Given below is the list of recent legal activities going on the following patents of Invega Hafyera.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eGrant Notification | 06 Jun, 2023 | US11666697 |
| Recordation of Patent eGrant | 06 Jun, 2023 | US11666697 |
| Recordation of Patent Grant Mailed Critical | 06 Jun, 2023 | US11666697 |
| Electronic Review Critical | 06 Jun, 2023 | US11666697 |
| Patent eGrant Notification | 06 Jun, 2023 | US11666697 |
| Email Notification Critical | 06 Jun, 2023 | US11666697 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Jun, 2023 | US11666697 |
| Email Notification Critical | 18 May, 2023 | US11666697 |
| Electronic Review Critical | 18 May, 2023 | US11666697 |
| Issue Notification Mailed Critical | 17 May, 2023 | US11666697 |
FDA has granted several exclusivities to Invega Hafyera. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Invega Hafyera, 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 Hafyera.
Exclusivity Information
Invega Hafyera holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Invega Hafyera's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | Aug 30, 2024 |
US patents provide insights into the exclusivity only within the United States, but Invega Hafyera 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 Hafyera's family patents as well as insights into ongoing legal events on those patents.
Invega Hafyera's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Invega Hafyera's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 24, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Invega Hafyera Generic API suppliers:
Paliperidone Palmitate is the generic name for the brand Invega Hafyera. 1 company has already filed for the generic of Invega Hafyera. Check out the entire list of companies who have already received approval for Invega Hafyera's generic
How can I launch a generic of Invega Hafyera before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Invega Hafyera's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Invega Hafyera'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 Hafyera -
| 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 Hafyera
Invega Hafyera which is used for long-term treatment of schizophrenia., has several other brand drugs 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 | ||
|---|---|---|---|
| Janssen Pharms |
| ||
| Luye Innomind Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Paliperidone Palmitate, Invega Hafyera's active ingredient. Check the complete list of approved generic manufacturers for Invega Hafyera
About Invega Hafyera
Invega Hafyera is a drug owned by Janssen Pharmaceuticals Inc. It is used for long-term treatment of schizophrenia. Invega Hafyera uses Paliperidone Palmitate as an active ingredient. Invega Hafyera was launched by Janssen Pharms in 2021.
Approval Date:
Invega Hafyera was approved by FDA for market use on 30 August, 2021.
Active Ingredient:
Invega Hafyera uses Paliperidone Palmitate as the active ingredient. Check out other Drugs and Companies using Paliperidone Palmitate ingredient
Treatment:
Invega Hafyera is used for long-term treatment of schizophrenia.
Dosage:
Invega Hafyera is available in suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.560GM/5ML (312MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 1.092GM/3.5ML (312MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |