Abilify Patent Expiration

Abilify is a drug owned by Otsuka Pharmaceutical Co Ltd. It is protected by 25 US drug patents filed from 2013 to 2016. Out of these, 5 drug patents are active and 20 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 02, 2027. Details of Abilify'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.
US8580796 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(1 year, 11 months ago)

Expired
US9359302 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(1 year, 11 months ago)

Expired
US8642760 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(1 year, 11 months ago)

Expired
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5006528 Carbostyril derivatives
Oct, 2014

(9 years ago)

Expired
US5006528

(Pediatric)

Carbostyril derivatives
Apr, 2015

(9 years ago)

Expired
US9358207 Flashmelt oral dosage formulation
Apr, 2020

(4 years ago)

Expired
US8518421 Flashmelt oral dosage formulation
Jan, 2021

(3 years ago)

Expired
US8518421

(Pediatric)

Flashmelt oral dosage formulation
Jul, 2021

(3 years ago)

Expired
US8642600 Method of treating autism
Jan, 2022

(2 years ago)

Expired
US7053092 5-HT1a receptor subtype agonist
Jan, 2022

(2 years ago)

Expired
US9089567 Method of treating cognitive impairments and schizophrenias
Jan, 2022

(2 years ago)

Expired
US6977257 Aripiprazole oral solution
Apr, 2022

(2 years ago)

Expired
US8642600

(Pediatric)

Method of treating autism
Jul, 2022

(2 years ago)

Expired
US6977257

(Pediatric)

Aripiprazole oral solution
Oct, 2022

(1 year, 10 months ago)

Expired
US8642760

(Pediatric)

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Mar, 2023

(1 year, 5 months ago)

Expired
US8580796

(Pediatric)

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Mar, 2023

(1 year, 5 months ago)

Expired
US9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Dec, 2023

(8 months ago)

Expired
US8017615 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Jun, 2024

(2 months ago)

Expired
US7550445 Aripiprazole complex formulation and method
Jul, 2024

(a month ago)

Expired
US7115587 Aripiprazole complex formulation and method
Jul, 2024

(a month ago)

Expired
US8017615

(Pediatric)

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Dec, 2024

(3 months from now)

Active
US7115587

(Pediatric)

Aripiprazole complex formulation and method
Jan, 2025

(4 months from now)

Active
US7550445

(Pediatric)

Aripiprazole complex formulation and method
Jan, 2025

(4 months from now)

Active
US9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders
Jul, 2026

(1 year, 10 months from now)

Active
US8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Mar, 2027

(2 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's patents.

Given below is the list of recent legal activities going on the following patents of Abilify.

Activity Date Patent Number
Patent litigations
Expire Patent 15 Jul, 2024 US9359302
Maintenance Fee Reminder Mailed 04 Mar, 2024 US9387182 (Litigated)
Maintenance Fee Reminder Mailed 29 Jan, 2024 US9359302
Payment of Maintenance Fee, 12th Year, Large Entity 01 Mar, 2023 US8017615 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 22 Feb, 2023 US9125939 (Litigated)
Expire Patent 04 Oct, 2021 US8518421 (Litigated)
Expire Patent 26 Jul, 2021 US7550445
Payment of Maintenance Fee, 8th Year, Large Entity 21 Jul, 2021 US8642760 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 28 Apr, 2021 US8580796 (Litigated)
Maintenance Fee Reminder Mailed 19 Apr, 2021 US8518421 (Litigated)


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 and ongoing litigations to help you estimate the early arrival of Abilify generic.

Abilify's Litigations

Abilify has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 17, 2016, against patent number US9125939. The petitioner Alkermes Pharma Ireland Limited, challenged the validity of this patent, with Otsuka Pharmaceutical Co., Ltd. as the respondent. Click below to track the latest information on how companies are challenging Abilify's patents.

Last updated on September 3, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9125939 November, 2016 Terminated-Denied
(04 May, 2017)
Otsuka Pharmaceutical Co., Ltd. Alkermes Pharma Ireland Limited


FDA has granted some exclusivities to Abilify. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Abilify, 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.

Exclusivity Information

Abilify holds 7 exclusivities. All of its exclusivities have expired in 2021. Details of Abilify's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Pediatric Exclusivity(PED) Aug 27, 2011
New Indication(I-616) Nov 19, 2012
New Indication(I-633) Feb 16, 2014
M(M-137) Jun 09, 2017
New Indication(I-700) Dec 12, 2017
Orphan Drug Exclusivity(ODE) Dec 12, 2021
Orphan Drug Exclusivity(ODE-80) Dec 12, 2021

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Several oppositions have been filed on Abilify'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's generic, the next section provides detailed information on ongoing and past EP oppositions related to Abilify patents.

Abilify's Oppositions Filed in EPO

Abilify 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
Patent litigations
EP04785621A Sep, 2017 Generics [UK] Ltd Revoked
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
EP11190103A Mar, 2016 Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi Patent maintained as amended
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 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's family patents as well as insights into ongoing legal events on those patents.

Abilify's Family Patents

Abilify has patent protection in a total of 44 countries. It's US patent count contributes only to 18.8% of its total global patent coverage. 15 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Abilify.

Family Patents



Generic Launch

Generic Release Date:

Abilify's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 02, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Abilify Generics:

Aripiprazole is the generic name for the brand Abilify. 27 different companies have already filed for the generic of Abilify, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Abilify's generic

How can I launch a generic of Abilify before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Abilify's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Abilify'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 -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
1 mg/mL 20 Dec, 2007 1 24 Apr, 2022 Extinguished
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg 15 Nov, 2006 8 20 Oct, 2014 Extinguished
10 mg, 15 mg, 20 mg and 30 mg 15 Nov, 2006 1 20 Oct, 2014 Extinguished

Abilify Competitors

Understanding your competition is essential for market success. Abilify which is used for treating manic episodes in bipolar disorder, major depressive disorder, irritability in autistic disorder, and maintaining stability in schizophrenia., has several other brand drugs in the same treatment category and using the same active ingredient (Aripiprazole). 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
Abbvie
Fetzima used for treating Major Depressive Disorder (MDD)
Viibryd Used for treating major depressive disorder (MDD).
Alkermes Inc
Aristada

(uses Aripiprazole)

Used for managing symptoms of schizophrenia through various methods of administration.
Aristada Initio Kit

(uses Aripiprazole)

Used for managing symptoms of schizophrenia.
Astrazeneca
Seroquel Xr Used for treating major depressive disorder (MDD) and schizophrenia.
Indivior
Perseris Kit Used for treating schizophrenia.
Intra-cellular
Caplyta Used for treating schizophrenia, bipolar depression, and bipolar disorder by modulating serotonin and dopamine receptor activity.
Janssen Pharms
Invega Trinza used for managing symptoms of schizophrenia in patients who have missed doses or need to restart treatment.
Invega Sustenna used for treating schizophrenia and schizoaffective disorder.
Risperdal Consta Used for maintenance treatment of bipolar I disorder and treatment of schizophrenia.
Osmotica Pharm Us
Venlafaxine Hydrochloride Used for treating major depressive disorder (MDD) and social anxiety disorder.
Otsuka
Rexulti used for treating major depressive disorder (MDD) and schizophrenia in adults and pediatric patients ages 13 years and older.
Abilify Mycite Kit

(uses Aripiprazole)

used for acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder (MDD), and treatment of schizophrenia.
Otsuka Pharm Co Ltd
Abilify Maintena Kit

(uses Aripiprazole)

Used for treating bipolar 1 disorder and schizophrenia, including during acute episodes.
Sunovion Pharms Inc
Latuda used for treating bipolar depression, major depressive episodes, and schizophrenia with improvement in attention function, negative symptoms, and cognitive dysfunction.
Teva
Uzedy Used for managing symptoms of schizophrenia.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Aripiprazole. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Otsuka
Abilify Asimtufii


Apart from brand drugs containing the same ingredient, some generics have also been filed for Aripiprazole, Abilify's active ingredient. Check the complete list of approved generic manufacturers for Abilify





About Abilify

Abilify is a drug owned by Otsuka Pharmaceutical Co Ltd. It is used for treating manic episodes in bipolar disorder, major depressive disorder, irritability in autistic disorder, and maintaining stability in schizophrenia. Abilify uses Aripiprazole as an active ingredient. Abilify was launched by Otsuka in 2002.

Approval Date:

Abilify was approved by FDA for market use on 15 November, 2002.

Active Ingredient:

Abilify uses Aripiprazole as the active ingredient. Check out other Drugs and Companies using Aripiprazole ingredient

Treatment:

Abilify is used for treating manic episodes in bipolar disorder, major depressive disorder, irritability in autistic disorder, and maintaining stability in schizophrenia.

Dosage:

Abilify is available in the following dosage forms - tablet form for oral use, injectable form for intramuscular use, tablet, orally disintegrating form for oral use, solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10MG TABLET Prescription ORAL
9.75MG/1.3ML (7.5MG/ML) INJECTABLE Discontinued INTRAMUSCULAR
30MG TABLET Prescription ORAL
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION Discontinued ORAL
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING Discontinued ORAL
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING Discontinued ORAL
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING Discontinued ORAL
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING Discontinued ORAL
15MG TABLET Prescription ORAL
20MG TABLET Prescription ORAL
5MG TABLET Prescription ORAL
2MG TABLET Prescription ORAL