Invega Sustenna is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2013 to 2016. Out of these, 1 drug patents are active and 8 have expired. Invega Sustenna's patents have been open to challenges since 01 February, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 26, 2031. Details of Invega Sustenna'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). | |||
| US9439906 | Dosing regimen associated with long acting injectable paliperidone esters |
Jan, 2031
(5 years from now) | Active |
|
US6555544 (Pediatric) | Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters |
May, 2019
(6 years ago) |
Expired
|
| US6555544 | Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters |
Nov, 2018
(6 years ago) |
Expired
|
|
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
(8 years ago) |
Expired
|
|
US5254556 (Pediatric) | 3-piperidinyl-1,2-benzisoxazoles |
Apr, 2014
(11 years ago) |
Expired
|
| US5254556 | 3-piperidinyl-1,2-benzisoxazoles |
Oct, 2013
(11 years ago) |
Expired
|
|
US5352459 (Pediatric) | Use of purified surface modifiers to prevent particle aggregation during sterilization |
Jun, 2013
(11 years ago) |
Expired
|
| US5352459 | Use of purified surface modifiers to prevent particle aggregation during sterilization |
Dec, 2012
(12 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 Sustenna's patents.
Latest Legal Activities on Invega Sustenna's Patents
Given below is the list of recent legal activities going on the following patents of Invega Sustenna.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Feb, 2024 | US9439906 |
| Electronic Review Critical | 25 Jan, 2022 | US9439906 |
| Email Notification Critical | 25 Jan, 2022 | US9439906 |
| Mail Certificate of Correction Memo | 24 Jan, 2022 | US9439906 |
| Certificate of Correction Memo | 06 Jan, 2022 | US9439906 |
| Post Issue Communication - Certificate of Correction | 06 Jan, 2022 | US9439906 |
| Request for Trial Denied Critical | 16 Sep, 2020 | US9439906 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Feb, 2020 | US9439906 |
| Petition Requesting Trial | 11 Feb, 2020 | US9439906 |
| Petition Requesting Trial | 07 Feb, 2020 | US9439906 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Invega Sustenna and ongoing litigations to help you estimate the early arrival of Invega Sustenna generic.
Invega Sustenna's Litigations
Invega Sustenna been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 07, 2020, against patent number US9439906. The petitioner Mylan Laboratories Ltd., challenged the validity of this patent, with Janssen Pharmaceutica NV as the respondent. Click below to track the latest information on how companies are challenging Invega Sustenna's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9439906 | February, 2020 |
Terminated-Denied
(16 Sep, 2020) | Janssen Pharmaceutica NV | Mylan Laboratories Ltd. |
FDA has granted some exclusivities to Invega Sustenna. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Invega Sustenna, 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 Sustenna.
Exclusivity Information
Invega Sustenna holds 6 exclusivities. All of its exclusivities have expired in 2020. Details of Invega Sustenna's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2011 |
| New Dosage Form(NDF) | Jul 31, 2012 |
| Pediatric Exclusivity(PED) | Jan 31, 2013 |
| M(M-119) | Aug 29, 2015 |
| New Indication(I-698) | Nov 12, 2017 |
| M(M-215) | Dec 20, 2020 |
Several oppositions have been filed on Invega Sustenna'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 Sustenna's generic, the next section provides detailed information on ongoing and past EP oppositions related to Invega Sustenna patents.
Invega Sustenna's Oppositions Filed in EPO
Invega Sustenna has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 31, 2021, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP08863534A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP08863534A | Dec, 2021 | EGIS Gyógyszergyár Zártkörüen Müködö Részvénytársaság | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Zentiva k.s. | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Hoffmann Eitle SLU | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Farmaprojects S.A.U. | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Gill Jennings & Every LLP | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Laboratorios Lesvi, S.L. | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Tolmar International Limited | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Sun Pharmaceutical Industries Europe B.V. | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte ParG mbB | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | BIOGARAN | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | EVER Valinject GmbH | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Hoffmann Eitle | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Maiwald Patent- und Rechtsanwaltsgesellschaft mbH | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Abbott Products Operations AG | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Stada-Arzneimittel Aktiengesellschaft | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Instone, Terry/Appleyard Lees IP LLP/Read, Howard | Granted and Under Opposition |
| EP08863534A | Dec, 2021 | Advanz Pharma Services (UK) Ltd. | Granted and Under Opposition |
| EP08863534A | Mar, 2021 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Invega Sustenna 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 Sustenna's family patents as well as insights into ongoing legal events on those patents.
Invega Sustenna's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Invega Sustenna's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 26, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Invega Sustenna Generic API suppliers:
Paliperidone Palmitate is the generic name for the brand Invega Sustenna. 1 company has already filed for the generic of Invega Sustenna. Check out the entire list of companies who have already received approval for Invega Sustenna's generic
How can I launch a generic of Invega Sustenna before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Invega Sustenna's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Invega Sustenna'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 Sustenna -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL | 21 Nov, 2017 | 1 | 06 Jul, 2021 | 26 Jan, 2031 | Deferred |
Alternative Brands for Invega Sustenna
Invega Sustenna which is used for treating schizophrenia and schizoaffective disorder., 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 Sustenna's active ingredient. Check the complete list of approved generic manufacturers for Invega Sustenna
About Invega Sustenna
Invega Sustenna is a drug owned by Janssen Pharmaceuticals Inc. It is used for treating schizophrenia and schizoaffective disorder. Invega Sustenna uses Paliperidone Palmitate as an active ingredient. Invega Sustenna was launched by Janssen Pharms in 2009.
Approval Date:
Invega Sustenna was approved by FDA for market use on 31 July, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Invega Sustenna is 31 July, 2009, its NCE-1 date is estimated to be 01 February, 2012.
Active Ingredient:
Invega Sustenna uses Paliperidone Palmitate as the active ingredient. Check out other Drugs and Companies using Paliperidone Palmitate ingredient
Treatment:
Invega Sustenna is used for treating schizophrenia and schizoaffective disorder.
Dosage:
Invega Sustenna is available in suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |