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, 4 drug patents are active and 21 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9359302 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Sep, 2022
(2 years ago) |
Expired
|
| US8642760 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Sep, 2022
(2 years ago) |
Expired
|
| US8580796 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Sep, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8759350 | Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders |
Mar, 2027
(2 years from now) | Active |
| US9125939 | Carbostyril derivatives and mood stabilizers for treating mood disorders |
Jul, 2026
(1 year, 7 months from now) | Active |
|
US7550445 (Pediatric) | Aripiprazole complex formulation and method |
Jan, 2025
(a month from now) | Active |
|
US7115587 (Pediatric) | Aripiprazole complex formulation and method |
Jan, 2025
(a month from now) | Active |
|
US8017615 (Pediatric) | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Dec, 2024
(2 days ago) |
Expired
|
| US7550445 | Aripiprazole complex formulation and method |
Jul, 2024
(4 months ago) |
Expired
|
| US7115587 | Aripiprazole complex formulation and method |
Jul, 2024
(4 months ago) |
Expired
|
| US8017615 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Jun, 2024
(6 months ago) |
Expired
|
| US9387182 | Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders |
Dec, 2023
(11 months ago) |
Expired
|
|
US8642760 (Pediatric) | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Mar, 2023
(1 year, 8 months ago) |
Expired
|
|
US8580796 (Pediatric) | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Mar, 2023
(1 year, 8 months ago) |
Expired
|
|
US6977257 (Pediatric) | Aripiprazole oral solution |
Oct, 2022
(2 years ago) |
Expired
|
|
US8642600 (Pediatric) | Method of treating autism |
Jul, 2022
(2 years ago) |
Expired
|
| US6977257 | Aripiprazole oral solution |
Apr, 2022
(2 years ago) |
Expired
|
| US7053092 | 5-HT1a receptor subtype agonist |
Jan, 2022
(2 years ago) |
Expired
|
| US8642600 | Method of treating autism |
Jan, 2022
(2 years ago) |
Expired
|
| US9089567 | Method of treating cognitive impairments and schizophrenias |
Jan, 2022
(2 years ago) |
Expired
|
|
US8518421 (Pediatric) | Flashmelt oral dosage formulation |
Jul, 2021
(3 years ago) |
Expired
|
| US8518421 | Flashmelt oral dosage formulation |
Jan, 2021
(3 years ago) |
Expired
|
| US9358207 | Flashmelt oral dosage formulation |
Apr, 2020
(4 years ago) |
Expired
|
|
US5006528 (Pediatric) | Carbostyril derivatives |
Apr, 2015
(9 years ago) |
Expired
|
| US5006528 | Carbostyril derivatives |
Oct, 2014
(10 years ago) |
Expired
|
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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent Critical | 15 Jul, 2024 | US9359302 |
| Maintenance Fee Reminder Mailed Critical | 04 Mar, 2024 | US9387182 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 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 Critical | 04 Oct, 2021 | US8518421 (Litigated) |
| Expire Patent Critical | 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 Critical | 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 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Abilify:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Abilify(Aripiprazole) has 2 clinical trials that have been verified in 2024. Out of these 2, 1 trial is in PHASE4.
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 Generic API suppliers:
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 |
Alternative Brands for Abilify
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 |
| |||||||
| Alkermes Inc |
| |||||||
| Astrazeneca |
| |||||||
| Indivior |
| |||||||
| Intra-cellular |
| |||||||
| Janssen Pharms |
| |||||||
| Osmotica Pharm Us |
| |||||||
| Otsuka |
| |||||||
| Otsuka Pharm Co Ltd |
| |||||||
| Sunovion Pharms Inc |
| |||||||
| Teva |
| |||||||
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 - injectable form for intramuscular use, tablet form for oral 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 |
|---|---|---|---|
| 2MG | TABLET | Prescription | ORAL |
| 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | ORAL |
| 15MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 30MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |
| 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE | Discontinued | INTRAMUSCULAR |
| 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 |