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The patent EP4125903 was granted to Otsuka Pharmaceutical on Oct 9, 2024. The application was originally filed on Apr 1, 2021 under application number EP21720012A. The patent is currently recorded with a legal status of "Granted And Under Opposition".
A two-injection initiation regimen for aripiprazole long-acting injectable (Ability Maintena) comprising two separate 300-400 mg intramuscular injections at different sites (gluteal and/or deltoid) on the first day of treatment, supplemented with a single oral dose of 2-30 mg aripiprazole, provides an alternative to the traditional 14-day oral overlap initiation regimen for patients with schizophrenia or bipolar I disorder.

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.
| Company | Opposition Date | Representative | Opposition Status |
|---|---|---|---|
| GENERICS UK | Jul 9, 2025 | RUSSELL | ADMISSIBLE |
| ZENTIVA | Jul 9, 2025 | GREINER | ADMISSIBLE |
| RUMI | Jul 8, 2025 | TER MEER STEINMEISTER & PARTNER | ADMISSIBLE |
| SANDOZ | Jul 4, 2025 | MAIWALD | ADMISSIBLE |
| DR SCHON | Jul 1, 2025 | DR SCHON | ADMISSIBLE |
| MAIWALD | Jul 1, 2025 | MAIWALD | ADMISSIBLE |
| STADA ARZNEIMITTEL | Jul 1, 2025 | HAMM & WITTKOPP | ADMISSIBLE |
Patent citations refer to prior patents cited during different phases such as opposition or international search.
| Citation Phase | Publication Number |
|---|---|
| DESCRIPTION | US10525057 |
| DESCRIPTION | US7807680 |
| DESCRIPTION | US8030313 |
| DESCRIPTION | US8338427 |
| DESCRIPTION | US8338428 |
| DESCRIPTION | US8399469 |
| DESCRIPTION | US8722679 |
| DESCRIPTION | US8759351 |
| DESCRIPTION | US8993761 |
| DESCRIPTION | US9089567 |
| INTERNATIONAL-SEARCH-REPORT | US2015087654 |
| INTERNATIONAL-SEARCH-REPORT | US2019099494 |
| OPPOSITION | CN110327296 |
| OPPOSITION | EP3607940 |
| OPPOSITION | US2015087654 |
| OPPOSITION | WO2005041937 |
| OPPOSITION | WO2009001697 |
| OPPOSITION | WO2021201239 |
The dossier documents provide a comprehensive record of the patent's prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent's legal journey and any challenges it may have faced during examination.
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Oct 22, 2024
Sep 12, 2024
Decision to grant a European patent
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Aug 30, 2024
(Electronic) Receipt
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Aug 30, 2024
Filing of the translations of the claims
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Aug 30, 2024
French translation of claims
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Aug 30, 2024
German translation of the claims
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Aug 30, 2024
Letter accompanying subsequently filed items
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Jul 9, 2024
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Intention to grant (signatures)
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Jul 9, 2024
Text intended for grant (clean copy)
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(Electronic) Receipt
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Jun 5, 2024
Citation filed by a third party
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Jun 5, 2024
Letter accompanying subsequently filed items
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Jun 5, 2024
Non-patent literature filed by a third party
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Jun 5, 2024
Non-patent literature filed by a third party
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Non-patent literature filed by a third party
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Observations by third parties
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May 16, 2024
(Electronic) Receipt
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May 16, 2024
Amended claims with annotations
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May 16, 2024
Amended description with annotations
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May 16, 2024
Claims
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May 16, 2024
Description
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May 16, 2024
Letter accompanying subsequently filed items
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May 16, 2024
Mar 22, 2024
Annex to the communication
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Mar 22, 2024
Communication from the Examining Division
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Jan 15, 2024
(Electronic) Receipt
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Jan 15, 2024
Amended claims with annotations
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Jan 15, 2024
Amended description with annotations
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Jan 15, 2024
Claims
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Jan 15, 2024
Description
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Jan 15, 2024
Letter accompanying subsequently filed items
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Jan 15, 2024
Sep 5, 2023
Annex to the communication
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Sep 5, 2023
Communication from the Examining Division
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Aug 28, 2023
Examination started
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May 17, 2023
(Electronic) Receipt
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May 17, 2023
May 17, 2023
Amended claims with annotations
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May 17, 2023
Amendments received before examination
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May 17, 2023
Letter accompanying subsequently filed items
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Jan 11, 2023
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Information regarding early processing
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Jun 9, 2022
(Electronic) Receipt
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Jun 9, 2022
Request for entry into the European phase
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Oct 25, 2021
Oct 7, 2021
Annex
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Oct 7, 2021
Copy of the international search report
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Oct 7, 2021
Published international application - A1
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