Abilify Asimtufii is a drug owned by Otsuka Pharmaceutical Co Ltd. It is protected by 7 US drug patents filed in 2023. Out of these, 5 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 23, 2033. Details of Abilify Asimtufii's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8399469 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Jun, 2025
(11 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8759351 | Methods for administering aripiprazole |
Aug, 2023
(11 months ago) |
Expired
|
| US8338428 | Methods for administering aripiprazole |
Aug, 2023
(11 months ago) |
Expired
|
| US8338427 | Methods for administering aripiprazole |
Mar, 2025
(7 months from now) | Active |
| US10517951 | Injectable preparation |
Apr, 2033
(8 years from now) | Active |
| US11097007 | Injectable preparation |
Apr, 2033
(8 years from now) | Active |
| US11638757 | Injectable preparation |
Apr, 2033
(8 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 Abilify Asimtufii's patents.
Latest Legal Activities on Abilify Asimtufii's Patents
Given below is the list of recent legal activities going on the following patents of Abilify Asimtufii.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jun, 2024 | US8338428 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jun, 2024 | US8338427 |
| Electronic Review | 23 Jun, 2023 | US11638757 |
| Mail Certificate of Correction Memo | 22 Jun, 2023 | US11638757 |
| Post Issue Communication - Certificate of Correction | 21 Jun, 2023 | US11638757 |
| Certificate of Correction Memo | 16 Jun, 2023 | US11638757 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Jun, 2023 | US10517951 |
| Electronic Review | 03 May, 2023 | US11638757 |
| Email Notification | 03 May, 2023 | US11638757 |
| Mail Miscellaneous Communication to Applicant | 02 May, 2023 | US11638757 |
Several oppositions have been filed on Abilify Asimtufii'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 Abilify Asimtufii's generic, the next section provides detailed information on ongoing and past EP oppositions related to Abilify Asimtufii patents.
Abilify Asimtufii's oppositions filed in EPO
Abilify Asimtufii has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 04, 2007, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP02782507A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08000358A | May, 2017 | Bülle Dr., Jan | Revoked |
| EP08000358A | May, 2017 | Teva Pharmaceutical Industries Ltd. | Revoked |
| EP08000358A | May, 2017 | CHEMO IBERICA, S.A. | Revoked |
| EP08000358A | Apr, 2017 | Pharmaceutical Works Polpharma | Revoked |
| EP04002427A | Jan, 2011 | Teva Pharmaceutical Industries Ltd. | Patent maintained as amended |
| EP02782507A | Jan, 2007 | Ratiopharm GmbH | Revoked |
| EP02782507A | Jan, 2007 | EGIS Gyógyszergyár Nyrt | Revoked |
| EP02782507A | Jan, 2007 | Pharmaceutical Works POLPHARMA | Revoked |
| EP02782507A | Jan, 2007 | Fermion Oy | Revoked |
| EP02782507A | Jan, 2007 | Teva Pharmaceutical Industries Ltd. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Abilify Asimtufii 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 Abilify Asimtufii's family patents as well as insights into ongoing legal events on those patents.
Abilify Asimtufii's family patents
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Generic Launch
Generic Release Date:
Abilify Asimtufii's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 23, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Abilify Asimtufii Generics:
Aripiprazole is the generic name for the brand Abilify Asimtufii. 27 different companies have already filed for the generic of Abilify Asimtufii, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Abilify Asimtufii's generic
About Abilify Asimtufii
Abilify Asimtufii is a drug owned by Otsuka Pharmaceutical Co Ltd. It is used for managing symptoms of bipolar I disorder and schizophrenia with extended-release injectable suspension. Abilify Asimtufii uses Aripiprazole as an active ingredient. Abilify Asimtufii was launched by Otsuka in 2023.
Market Authorisation Date:
Abilify Asimtufii was approved by FDA for market use on 27 April, 2023.
Active Ingredient:
Abilify Asimtufii uses Aripiprazole as the active ingredient. Check out other Drugs and Companies using Aripiprazole ingredient
Treatment:
Abilify Asimtufii is used for managing symptoms of bipolar I disorder and schizophrenia with extended-release injectable suspension.
Dosage:
Abilify Asimtufii is available in suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 960MG/3.2ML (300MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 720MG/2.4ML (300MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |