Abilify Maintena Kit is a drug owned by Otsuka Pharmaceutical Co Ltd. It is protected by 17 US drug patents filed from 2013 to 2023. Out of these, 11 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 06, 2034. Details of Abilify Maintena 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US5006528 | Carbostyril derivatives |
Oct, 2014
(9 years ago) |
Expired
|
| US8993761 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Sep, 2022
(1 year, 10 months ago) |
Expired
|
| 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). | |||
|
US5006528 (Pediatric) | Carbostyril derivatives |
Apr, 2015
(9 years ago) |
Expired
|
| US5006528 | Carbostyril derivatives |
Apr, 2015
(9 years ago) |
Expired
|
| US9089567 | Method of treating cognitive impairments and schizophrenias |
Jan, 2022
(2 years ago) |
Expired
|
| US8338428 | Methods for administering aripiprazole |
Aug, 2023
(11 months ago) |
Expired
|
| US8759351 | Methods for administering aripiprazole |
Aug, 2023
(11 months ago) |
Expired
|
| US8030313 | Controlled release sterile injectable aripiprazole formulation and method |
Oct, 2024
(2 months from now) | Active |
| US7807680 | Controlled release sterile injectable aripiprazole formulation and method |
Oct, 2024
(2 months from now) | Active |
| US8722679 | Controlled release sterile injectable aripiprazole formulation and method |
Oct, 2024
(2 months from now) | Active |
| US8338427 | Methods for administering aripiprazole |
Mar, 2025
(7 months from now) | Active |
| US11154553 | Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function |
Sep, 2033
(9 years from now) | Active |
| US11400087 | Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function |
Sep, 2033
(9 years from now) | Active |
| US11344547 | Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function |
Sep, 2033
(9 years from now) | Active |
| US10980803 | Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function |
Sep, 2033
(9 years from now) | Active |
| US10525057 | Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function |
Mar, 2034
(9 years from now) | Active |
| US11648347 | Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient |
Apr, 2034
(9 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 Maintena Kit's patents.
Latest Legal Activities on Abilify Maintena Kit's Patents
Given below is the list of recent legal activities going on the following patents of Abilify Maintena Kit.
| 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 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Jun, 2023 | US10525057 |
| Patent Issue Date Used in PTA Calculation | 16 May, 2023 | US11648347 |
| Mail Patent eGrant Notification | 16 May, 2023 | US11648347 |
| Patent eGrant Notification | 16 May, 2023 | US11648347 |
| Recordation of Patent Grant Mailed | 16 May, 2023 | US11648347 |
| Electronic Review | 16 May, 2023 | US11648347 |
| Recordation of Patent eGrant | 16 May, 2023 | US11648347 |
| Email Notification | 16 May, 2023 | US11648347 |
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 Abilify Maintena Kit and ongoing litigations to help you estimate the early arrival of Abilify Maintena Kit generic.
Abilify Maintena Kit's Litigations
Abilify Maintena Kit has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 09, 2017, against patent number US10525057. The petitioner , challenged the validity or infringement of this patent, with Raoufinia, Arash as the respondent. Click below to track the latest information on how companies are challenging Abilify Maintena Kit's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10525057 | June, 2017 | Decision | Raoufinia, Arash | |
FDA has granted some exclusivities to Abilify Maintena Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Abilify Maintena 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 Abilify Maintena Kit.
Exclusivity Information
Abilify Maintena Kit holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Abilify Maintena Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Feb 28, 2016 |
| M(M-150) | Dec 05, 2017 |
| New Indication(I-746) | Jul 27, 2020 |
Several oppositions have been filed on Abilify Maintena 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 Abilify Maintena Kit's generic, the next section provides detailed information on ongoing and past EP oppositions related to Abilify Maintena Kit patents.
Abilify Maintena Kit's oppositions filed in EPO
Abilify Maintena Kit 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 |
| EP04795514A | Jul, 2009 | Alkermes, Inc. | 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 Maintena 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 Abilify Maintena Kit's family patents as well as insights into ongoing legal events on those patents.
Abilify Maintena Kit's family patents
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Generic Launch
Generic Release Date:
Abilify Maintena Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 06, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Abilify Maintena Kit Generics:
Aripiprazole is the generic name for the brand Abilify Maintena Kit. 27 different companies have already filed for the generic of Abilify Maintena Kit, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Abilify Maintena Kit's generic
How can I launch a generic of Abilify Maintena Kit before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Abilify Maintena Kit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Abilify Maintena Kit'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 Abilify Maintena Kit -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg/vial and 400 mg/vial | 20 Dec, 2021 | 1 | 24 Sep, 2033 |
About Abilify Maintena Kit
Abilify Maintena Kit is a drug owned by Otsuka Pharmaceutical Co Ltd. It is used for treating bipolar 1 disorder and schizophrenia, including during acute episodes. Abilify Maintena Kit uses Aripiprazole as an active ingredient. Abilify Maintena Kit was launched by Otsuka Pharm Co Ltd in 2013.
Market Authorisation Date:
Abilify Maintena Kit was approved by FDA for market use on 28 February, 2013.
Active Ingredient:
Abilify Maintena Kit uses Aripiprazole as the active ingredient. Check out other Drugs and Companies using Aripiprazole ingredient
Treatment:
Abilify Maintena Kit is used for treating bipolar 1 disorder and schizophrenia, including during acute episodes.
Dosage:
Abilify Maintena Kit is available in for suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG | FOR SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 400MG | FOR SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |