Aristada Initio Kit is a drug owned by Alkermes Inc. It is protected by 8 US drug patents filed from 2018 to 2022 out of which none have expired yet. Aristada Initio Kit'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 Initio Kit'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 |
| US10016415 | Aripiprazole prodrug compositions |
Sep, 2035
(10 years from now) | Active |
| US11154552 | Aripiprazole prodrug composition |
Aug, 2035
(10 years from now) | Active |
| US10849894 | Aripiprazole prodrug composition |
Aug, 2035
(10 years from now) | Active |
| US10688091 | Aripiprazole prodrug composition |
Aug, 2035
(10 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 Initio Kit's patents.
Latest Legal Activities on Aristada Initio Kit's Patents
Given below is the list of recent legal activities going on the following patents of Aristada Initio Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jun, 2024 | US10849894 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Dec, 2023 | US10688091 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 May, 2022 | US10112903 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Mar, 2022 | US11273158 |
| Recordation of Patent Grant Mailed Critical | 15 Mar, 2022 | US11273158 |
| Email Notification Critical | 24 Feb, 2022 | US11273158 |
| Issue Notification Mailed Critical | 23 Feb, 2022 | US11273158 |
| Application Is Considered Ready for Issue Critical | 07 Feb, 2022 | US11273158 |
| Dispatch to FDC | 07 Feb, 2022 | US11273158 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Feb, 2022 | US8796276 |
FDA has granted several exclusivities to Aristada Initio Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aristada Initio Kit, 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 Initio Kit.
Exclusivity Information
Aristada Initio Kit holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Aristada Initio Kit'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 Initio Kit'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 Initio Kit's generic, the next section provides detailed information on ongoing and past EP oppositions related to Aristada Initio Kit patents.
Aristada Initio Kit's Oppositions Filed in EPO
Aristada Initio Kit has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 21, 2018, by Generics (Uk) Ltd. This opposition was filed on patent number EP10792677A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15750750A | Nov, 2019 | Generics (UK) Ltd | Patent maintained as amended |
| EP10792677A | Mar, 2018 | Generics (UK) Ltd | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Aristada Initio Kit 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 Initio Kit's family patents as well as insights into ongoing legal events on those patents.
Aristada Initio Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aristada Initio Kit'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 Initio Kit Generics:
There are no approved generic versions for Aristada Initio Kit as of now.
Alternative Brands for Aristada Initio Kit
Aristada Initio Kit which is used for managing symptoms of schizophrenia., 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 Initio Kit
Aristada Initio Kit is a drug owned by Alkermes Inc. It is used for managing symptoms of schizophrenia. Aristada Initio Kit uses Aripiprazole Lauroxil as an active ingredient. Aristada Initio Kit was launched by Alkermes Inc in 2018.
Approval Date:
Aristada Initio Kit was approved by FDA for market use on 29 June, 2018.
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 Initio Kit is 29 June, 2018, its NCE-1 date is estimated to be 06 October, 2019.
Active Ingredient:
Aristada Initio Kit uses Aripiprazole Lauroxil as the active ingredient. Check out other Drugs and Companies using Aripiprazole Lauroxil ingredient
Treatment:
Aristada Initio Kit is used for managing symptoms of schizophrenia.
Dosage:
Aristada Initio Kit is available in suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 675MG/2.4ML (281.25MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |