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Last Updated: December 23, 2024

Aripiprazole - Generic Drug Details


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What are the generic drug sources for aripiprazole and what is the scope of patent protection?

Aripiprazole is the generic ingredient in eight branded drugs marketed by Xiamen Lp Pharm Co, Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in forty-four NDAs. There are sixty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aripiprazole has nine hundred and one patent family members in forty-eight countries.

There are forty-nine drug master file entries for aripiprazole. Fifty suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for aripiprazole

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Drug Sales Revenue Trends for aripiprazole

See drug sales revenues for aripiprazole

Recent Clinical Trials for aripiprazole

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Consorcio Centro de Investigación Biomédica en Red (CIBER)Phase 4
Instituto de Salud Carlos IIIPhase 4
First Affiliated Hospital Xi'an Jiaotong UniversityN/A

See all aripiprazole clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe30MGTABLET; ORALLY DISINTEGRATING
⤷  Subscribe⤷  Subscribe20MGTABLET, ORALLY DISINTEGRATING; ORAL
⤷  Subscribe⤷  Subscribe15MGTABLET, ORALLY DISINTEGRATING; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for aripiprazole
Medical Subject Heading (MeSH) Categories for aripiprazole
Anatomical Therapeutic Chemical (ATC) Classes for aripiprazole
Paragraph IV (Patent) Challenges for ARIPIPRAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ABILIFY MAINTENA KIT Extended-release Injectable Suspension aripiprazole 300 mg/vial and 400 mg/vial 202971 1 2021-12-20
ABILIFY Oral Solution aripiprazole 1 mg/mL 021713 1 2007-12-20
ABILIFY Tablets aripiprazole 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg 021436 8 2006-11-15
ABILIFY Orally Disintegrating Tablets aripiprazole 10 mg, 15 mg, 20 mg and 30 mg 021729 1 2006-11-15

US Patents and Regulatory Information for aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms ARIPIPRAZOLE aripiprazole TABLET;ORAL 204838-002 Jun 17, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc ARIPIPRAZOLE aripiprazole TABLET;ORAL 206383-001 Sep 29, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms ARIPIPRAZOLE aripiprazole SOLUTION;ORAL 203906-001 Aug 14, 2015 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkermes Inc ARISTADA aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533-001 Oct 5, 2015 RX Yes No 11,273,158 ⤷  Subscribe ⤷  Subscribe
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 RX Yes No 8,258,962 ⤷  Subscribe Y ⤷  Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 RX Yes No 8,338,427 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 8,017,615*PED ⤷  Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 8,017,615*PED ⤷  Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 7,053,092 ⤷  Subscribe
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 8,338,428 ⤷  Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006 5,006,528*PED ⤷  Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 8,722,679 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for aripiprazole

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) aripiprazole EMEA/H/C/003803
Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised yes no no 2015-06-30
Otsuka Pharmaceutical Netherlands B.V. Abilify aripiprazole EMEA/H/C/000471
Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised no no no 2004-06-04
Otsuka Pharmaceutical Netherlands B.V. Abilify Maintena aripiprazole EMEA/H/C/002755
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Authorised no no no 2013-11-14
Accord Healthcare S.L.U. Aripiprazole Accord aripiprazole EMEA/H/C/004021
Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment., , Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.,
Authorised yes no no 2015-11-15
Zentiva, k.s. Aripiprazole Zentiva aripiprazole EMEA/H/C/003899
Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised yes no no 2015-06-25
Sandoz GmbH Aripiprazole Sandoz aripiprazole EMEA/H/C/004008
Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment., , Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.,
Authorised yes no no 2015-08-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for aripiprazole

Country Patent Number Title Estimated Expiration
Ukraine 82561 СТЕРИЛЬНАЯ ИНЪЕКЦИОННАЯ КОМПОЗИЦИЯ АРИПИПРАЗОЛА С КОНТРОЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ, СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ И СПОСОБ ЛЕЧЕНИЯ ШИЗОФРЕНИИ;СТЕРИЛЬНА ІН'ЄКЦІЙНА КОМПОЗИЦІЯ АРИПІПРАЗОЛУ З КОНТРОЛЬОВАНИМ ВИВІЛЬНЕННЯМ, СПОСІБ ЇЇ ВИГОТОВЛЕННЯ ТА СПОСІБ ЛІКУВАННЯ ШИЗОФРЕНІЇ (CONTROLLED RELEASE STERILE ARIPIPRAZOLE FORMULATION FOR INJECTIONS, METHOD FOR PREPARING ARIPIPRAZOLE FORMULATION, AND METHOD FOR TREATING SCHIZOPHRENIA) ⤷  Subscribe
Norway 333291 ⤷  Subscribe
Portugal 1419776 ⤷  Subscribe
China 101434574 ⤷  Subscribe
Israel 169358 תכשיר רוקחות המכיל אריפיפרזול או מטבוליט שלו ומעכבי ספיגה חוזרת של סרוטונין להכנת תרופה לטיפול בהפרעות מצב רוח (Pharmaceutical composition comprising aripiprazole or a metabolite and serotonin reuptake inhibitors and its use in the manufacture of a medicament for treatment of mood disorders) ⤷  Subscribe
Slovenia 1575590 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aripiprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 C01675573/01 Switzerland ⤷  Subscribe PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
1675573 C300669 Netherlands ⤷  Subscribe PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 92427 Luxembourg ⤷  Subscribe PRODUCT NAME: ARIPIPRAZOLE
1675573 C20140014 00322 Estonia ⤷  Subscribe PRODUCT NAME: ARIPIPRASOOL;REG NO/DATE: K(2013)8163 (LOPLIK) 19.11.2013
1675573 122014000057 Germany ⤷  Subscribe PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 CA 2014 00026 Denmark ⤷  Subscribe PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Aripiprazole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aripiprazole

Introduction

Aripiprazole, a widely used antipsychotic medication, is experiencing significant market dynamics and financial shifts. This article delves into the current market size, growth projections, key drivers, and challenges facing the aripiprazole market.

Current Market Size and Growth Projections

The global aripiprazole market was valued at US$ 121 million in 2023 and is expected to reach US$ 167.1 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.1% during the forecast period of 2024-2030[1].

Another analysis suggests that the market will grow at a CAGR of 4.60% from 2022 to 2029, driven by increasing prevalence of mental health disorders such as depression, schizophrenia, and bipolar mania[3].

Key Drivers of Market Growth

Several factors are driving the growth of the aripiprazole market:

Increasing Prevalence of Mental Health Disorders

The rise in the prevalence of depression, schizophrenia, and bipolar mania globally is a major driver for the expansion of the aripiprazole market. As mental health awareness increases, so does the demand for effective treatments like aripiprazole[3].

Geriatric Population and Healthcare Expenditure

The increasing geriatric population and rising healthcare expenditure are also significant drivers. Older adults are more likely to suffer from mental health disorders, and increased healthcare spending supports the development and use of antipsychotic medications[3].

Research and Development Activities

Emerging new markets and the rise in research and development activities are providing beneficial opportunities for the aripiprazole market. New formulations and delivery methods, such as long-acting injectable solutions, are enhancing treatment options and patient compliance[3][5].

Market Segmentation

The aripiprazole market is segmented based on several criteria:

By Drug Class

Aripiprazole falls under the categories of antipsychotics and antimanic agents[3].

By Application

The drug is used to treat major depressive disorders, schizophrenia, bipolar mania, and other mental health conditions[3].

By Demographic

The market is segmented into adult and pediatric patients, with each demographic having different treatment needs and market dynamics[3].

By Dosage Form

Aripiprazole is available in various forms, including tablets, orally disintegrating tablets, oral solution, and injections. The long-acting injectable (LAI) solutions are particularly noteworthy for their convenience and compliance benefits[3][5].

Geographical Distribution

North America currently dominates the aripiprazole market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure. However, the Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support[3].

Financial Trajectory and Challenges

Revenue Growth

The financial performance of the aripiprazole market is robust, with revenue expected to grow steadily over the forecast period. Companies like Otsuka Pharmaceutical, Teva, and others are driving this growth through their strategic brands and new product launches[1][5].

Patent Expiry and Competition

The dual patent expiry of Abilify Maintena, a key product of Otsuka Pharmaceutical, poses a significant risk. This expiry is expected to lead to a 12% reduction in sales from 2024 to 2025 and could plummet further by the end of 2029. However, Otsuka is proactively developing new formulations, such as Abilify Asimtufii, to offset these losses and maintain market share[5].

Strategic Initiatives by Key Players

Companies are adopting several strategies to maintain and grow their market share:

New Formulations

Otsuka Pharmaceutical's launch of Abilify Asimtufii, a once-every-two-month LAI solution, is a significant example. This new formulation is expected to enhance patient compliance and provide a competitive edge despite the patent expiry of Abilify Maintena[5].

Global Rollout

The global rollout of new products, such as Vyepti by Lundbeck, and the expansion of existing products into new markets are also key strategies. These initiatives help in maintaining revenue growth and market dominance[2].

Impact on Patient Accessibility

The patent expiry of Abilify Maintena, while challenging for Otsuka, can translate into a positive outcome for the wider market. Increased competition and lower prices can make the drug more accessible to a larger patient population, which is a beneficial outcome for public health[5].

Regulatory and Market Trends

Regulatory Approvals

Recent regulatory approvals, such as the FDA approval of Abilify Asimtufii and the favorable FDA AdCom votes for brexpiprazole, indicate a supportive regulatory environment for new psychiatric treatments[2].

Market Competition

The market is competitive, with several key players including Otsuka Pharmaceutical, Teva, APOTEX, and others. The competition is expected to increase with the entry of generic versions post-patent expiry, which will drive innovation and cost-effectiveness[1].

Patient Epidemiology Analysis

The patient epidemiology analysis highlights the growing need for effective treatments. Factors such as disease epidemiology, country demographics, and import-export tariffs are crucial in forecasting the market scenario for individual countries[3].

Key Takeaways

  • The global aripiprazole market is expected to grow at a CAGR of 5.1% from 2024 to 2030.
  • Key drivers include the increasing prevalence of mental health disorders, rising geriatric population, and growing healthcare expenditure.
  • New formulations and delivery methods, such as LAI solutions, are enhancing treatment options.
  • North America dominates the market, but the Asia-Pacific region is expected to grow significantly.
  • Patent expiry of key products poses challenges, but companies are developing new formulations to maintain market share.
  • Increased competition post-patent expiry can make the drug more accessible to a larger patient population.

Frequently Asked Questions (FAQs)

Q: What is the expected growth rate of the global aripiprazole market from 2024 to 2030? A: The global aripiprazole market is expected to grow at a CAGR of 5.1% from 2024 to 2030[1].

Q: Which regions dominate the aripiprazole market? A: North America currently dominates the market, but the Asia-Pacific region is expected to grow significantly during the forecast period[3].

Q: What are the main drivers of the aripiprazole market growth? A: The main drivers include the increasing prevalence of mental health disorders, rising geriatric population, and growing healthcare expenditure[3].

Q: How will the patent expiry of Abilify Maintena impact Otsuka Pharmaceutical? A: The patent expiry is expected to lead to a 12% reduction in sales from 2024 to 2025, but Otsuka is developing new formulations to offset these losses[5].

Q: What are the new formulations being developed by key players? A: Otsuka Pharmaceutical has launched Abilify Asimtufii, a once-every-two-month LAI solution, to enhance patient compliance and maintain market share[5].

Cited Sources:

  1. Global Aripiprazole Drug Market Research Report 2024 - Valuates Reports
  2. Financial results and business update - Lundbeck - Lundbeck
  3. Global Aripiprazole Market - Industry Trends and Forecast to 2029 - Data Bridge Market Research
  4. Global Aripiprazole Market Size, Trends and Projections - Market Research Intellect
  5. Otsuka's new formulations to offset Abilify Maintena dual patent expiry impact - Financial Express

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.