Aristada is a drug owned by Alkermes Inc. It is protected by 13 US drug patents filed from 2015 to 2022 out of which none have expired yet. Aristada's patents have been open to challenges since 06 October, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 06, 2039. Details of Aristada's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8431576 | Heterocyclic compounds for the treatment of neurological and psychological disorders |
Oct, 2030
(5 years from now) | Active |
| US10112903 | Heterocyclic compounds for the treatment of neurological and psychological disorders |
Jun, 2030
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11273158 | Aripiprazole dosing strategy |
Apr, 2039
(14 years from now) | Active |
| US10813928 | Aripiprazole formulations having increased injection speeds |
Mar, 2035
(10 years from now) | Active |
| US10238651 | Aripiprazole formulations having increased injection speeds |
Mar, 2035
(10 years from now) | Active |
| US11406632 | Aripiprazole formulations having increased injection speeds |
Mar, 2035
(10 years from now) | Active |
| US9452131 | Aripiprazole formulations having increased injection speeds |
Mar, 2035
(10 years from now) | Active |
| US9526726 | Aripiprazole formulations having increased injection speeds |
Mar, 2035
(10 years from now) | Active |
| US11097006 | Pharmaceutical compositions having improved storage stability |
Oct, 2033
(8 years from now) | Active |
| US9193685 | Pharmaceutical compositions having improved storage stability |
Oct, 2033
(8 years from now) | Active |
| US9034867 | Pharmaceutical compositions comprising sorbitan esters |
Nov, 2032
(7 years from now) | Active |
| US10226458 | Pharmaceutical compositions comprising sorbitan esters |
Mar, 2032
(7 years from now) | Active |
| US8796276 | Heterocyclic compounds for the treatment of neurological and psychological disorders |
Jun, 2030
(5 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 Aristada's patents.
Latest Legal Activities on Aristada's Patents
Given below is the list of recent legal activities going on the following patents of Aristada.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Jun, 2024 | US9526726 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Apr, 2024 | US10813928 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Mar, 2024 | US9452131 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 May, 2023 | US9193685 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Nov, 2022 | US9034867 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Sep, 2022 | US10238651 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Sep, 2022 | US10226458 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Aug, 2022 | US11406632 |
| Recordation of Patent Grant Mailed Critical | 09 Aug, 2022 | US11406632 |
| Email Notification Critical | 21 Jul, 2022 | US11406632 |
FDA has granted several exclusivities to Aristada. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aristada, 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 Aristada.
Exclusivity Information
Aristada holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Aristada's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 05, 2020 |
Several oppositions have been filed on Aristada'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 Aristada's generic, the next section provides detailed information on ongoing and past EP oppositions related to Aristada patents.
Aristada's Oppositions Filed in EPO
Aristada has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 24, 2017, by Generics (Uk) Ltd. This opposition was filed on patent number EP12712189A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10792677A | Mar, 2018 | Generics (UK) Ltd | Patent maintained as amended |
| EP12712189A | May, 2017 | Generics (UK) Ltd | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Aristada 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 Aristada's family patents as well as insights into ongoing legal events on those patents.
Aristada's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aristada's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 06, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aristada Generics:
There are no approved generic versions for Aristada as of now.
Alternative Brands for Aristada
Aristada which is used for managing symptoms of schizophrenia through various methods of administration., has several other brand drugs in the same treatment category and using the same active ingredient (Aripiprazole Lauroxil). 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 |
| |||||||||
About Aristada
Aristada is a drug owned by Alkermes Inc. It is used for managing symptoms of schizophrenia through various methods of administration. Aristada uses Aripiprazole Lauroxil as an active ingredient. Aristada was launched by Alkermes Inc in 2015.
Approval Date:
Aristada was approved by FDA for market use on 05 October, 2015.
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 Aristada is 05 October, 2015, its NCE-1 date is estimated to be 06 October, 2019.
Active Ingredient:
Aristada uses Aripiprazole Lauroxil as the active ingredient. Check out other Drugs and Companies using Aripiprazole Lauroxil ingredient
Treatment:
Aristada is used for managing symptoms of schizophrenia through various methods of administration.
Dosage:
Aristada is available in suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1064MG/3.9ML (272.82MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 662MG/2.4ML (275.83MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 441MG/1.6ML (275.63MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 882MG/3.2ML (275.63MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |