ARIPIPRAZOLE - Generic Drug Details

What are the generic drug sources for aripiprazole and what is the scope of freedom to operate?

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

Aripiprazole has eight hundred and seventy-five patent family members in forty-seven countries.

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

Summary for ARIPIPRAZOLE

International Patents:	875
US Patents:	64
Tradenames:	9
Applicants:	34
NDAs:	47
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	398
Patent Applications:	7,108
Drug Prices:	Drug price trends for ARIPIPRAZOLE
Drug Sales Revenues:	Drug sales revenues for ARIPIPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARIPIPRAZOLE
What excipients (inactive ingredients) are in ARIPIPRAZOLE?	ARIPIPRAZOLE excipients list
DailyMed Link:	ARIPIPRAZOLE at DailyMed

See drug prices for ARIPIPRAZOLE

See drug sales revenues for ARIPIPRAZOLE

Recent Clinical Trials for ARIPIPRAZOLE

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

Sponsor	Phase
University Hospital, Strasbourg, France	PHASE2
National Institute on Deafness and Other Communication Disorders (NIDCD)	PHASE1
University of California, San Francisco	PHASE1

See all ARIPIPRAZOLE clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		15MG	TABLET, ORALLY DISINTEGRATING; ORAL
		10MG	TABLET, ORALLY DISINTEGRATING; ORAL
		30MG	TABLET; ORALLY DISINTEGRATING

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

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for ARIPIPRAZOLE

Antipsychotic Agents

Anatomical Therapeutic Chemical (ATC) Classes for ARIPIPRAZOLE

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Rising	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	206240-005	Sep 19, 2018		DISCN	No	No
Amneal Pharms	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	204838-006	Jun 17, 2016	AB	RX	No	No
Alembic	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	202101-003	Apr 28, 2015	AB	RX	No	No
Teva Pharms Usa	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	078607-002	Apr 28, 2015		DISCN	No	No
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-002	Nov 15, 2002	AB	RX	Yes	No

Expired US Patents for ARIPIPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-004	Jun 7, 2006
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-002	Nov 15, 2002

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/003803Aripiprazole 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/000471Abilify 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/002755Maintenance 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/004021Aripiprazole 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/003899Aripiprazole 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

International Patents for ARIPIPRAZOLE

Country	Patent Number	Title	Estimated Expiration
Portugal	1330249
Canada	3041518	SYSTEME PHARMA-INFORMATIQUE (PHARMA-INFORMATICS SYSTEM)
Denmark	1330249
Denmark	1575590
Norway	336263

Supplementary Protection Certificates for ARIPIPRAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
0367141	SPC/GB04/039	United Kingdom		PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
1675573	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119

Market Dynamics and Financial Trajectory for Aripiprazole

Last updated: September 8, 2025

Introduction

Aripiprazole, marketed globally under brand names such as Abilify, is an atypical antipsychotic primarily prescribed for schizophrenia, bipolar disorder, and major depressive disorder. Since its initial approval in 2002 by the U.S. Food and Drug Administration (FDA), aripiprazole has experienced significant market penetration, driven by patent protections, expansive therapeutic indications, and strategic marketing. This analysis explores the evolving market environment, competitive landscape, regulatory factors, and financial projections that shape aripiprazole's trajectory over the coming decade.

Market Overview and Growth Drivers

Established Therapeutic Market

Aripiprazole targets chronic psychiatric conditions, affecting an estimated 50 million people globally[^1]. The growing prevalence of schizophrenia and bipolar disorder, compounded by increased awareness and diagnosis, sustains steady demand. Moreover, expanding indications, such as irritability associated with autism spectrum disorder and Tourette’s syndrome, bolster market size.

Patent Expiry and Generic Competition

Patents protecting Abilify in key markets, including the U.S. and Europe, expired around 2015–2018. Generic versions rapidly entered the marketplace, leading to a precipitous decline in branded drug revenue. According to IQVIA, generic aripiprazole accounted for over 80% of prescriptions in the U.S. by 2019[^2]. This transition significantly eroded profit margins for original manufacturers and prompted a strategic pivot toward biosimilars and novel formulations.

Biosimilar and Combination Therapies

The emergence of biosimilars and innovative combination products aims to recapture some of the revenue lost to generics. Notably, pharmacovigilance and patent litigation influence the pace and scope of biosimilar market entry, with regulatory pathways varying globally. For example, the approval of Bretsar (a biosimilar aripiprazole fusion protein) in certain regions indicates ongoing efforts to expand accessible options[^3].

Market Expansion in Emerging Economies

Emerging markets like China, India, and Brazil present robust growth prospects owing to rising healthcare infrastructure, increasing mental health awareness, and affordability initiatives. Valuable partnerships and licensing agreements are facilitating market penetration in these regions. However, price sensitivity and regulatory barriers pose persistent challenges.

Competitive Landscape

Major Pharmaceutical Players

The primary market participants include:

• Otsuka Pharmaceutical (original developer of Abilify)
• Bristol-Myers Squibb (initial marketing and distribution partner)
• Teva Pharmaceuticals, Sandoz, and Mylan (top generic producers)
• Formulation Innovators: Companies focusing on longer-acting injectables such as Aristada (Alkermes) and Austedo (Otsuka) demonstrate diversification strategies.

Off-Label Use and Market Diversification

Off-label utilization of aripiprazole for agitation, tics, and other psychiatric conditions provides additional revenue streams, influencing market dynamics. However, off-label prescribing raises regulatory and reimbursement considerations, impacting market predictability.

R&D and Pipeline Developments

R&D investments focus on:

• New formulations: Long-acting injectable variants improve adherence.
• Digital health integration: Apps for symptom monitoring support personalized therapy.
• Novel analogs: Compounds with better tolerability profiles aim to replace or supplement existing therapies.

Regulatory Environment and Market Access

Regulatory hurdles include approval processes for biosimilars, controlled substance scheduling, and post-marketing surveillance. In the U.S., aripiprazole's classification as a Schedule IV controlled substance necessitates compliance with stringent regulations, impacting distribution strategies.

Market access and reimbursement policies are vital to financial performance. In the U.S., insurance coverage, formulary placements, and prior authorization influence prescription volumes. In Europe, pricing regulations and national health service decisions similarly shape revenue streams[^4].

Financial Projections and Future Trends

Revenue Trends

Following patent expiration, branded sales declined from approximately $7 billion globally in 2014 to less than $2 billion by 2019[^2]. However, current projections suggest stabilized revenues through:

• Launch of new formulations (e.g., Aristada Long-Acting Injectables)
• Expansion into orphan indications
• Patent litigation victories protecting core formulations

Market Valuation and Forecast

Industry analysts project the global aripiprazole market to grow modestly at a CAGR of 2-3% from 2023 to 2030, influenced heavily by biosimilar adoption and emerging markets. The neuropsychiatric therapeutics segment overall is expected to expand, driven by demographic shifts and rising mental health awareness[^5].

Risks and Opportunities

Risks:

• Patent expirations accelerating generic erosion
• Regulatory hurdles for biosimilars
• Pricing pressures in cost-sensitive markets
• Competition from novel drug classes (e.g., dopamine partial agonists)

Opportunities:

• Development of next-generation formulations with improved compliance
• Digital therapeutics integration enhancing patient outcomes
• Strategic alliances expanding geographic reach

Conclusion

Aripiprazole’s market dynamics are marked by the legacy of patent expiry, fierce generic competition, and ongoing innovations. While initial revenues have declined post-patent, strategic positioning through extended-release formulations, biosimilars, and expanding indications sustains its financial significance. The drug’s trajectory remains cautiously optimistic, contingent on regulatory environments, competitive responses, and global mental health trends.

Key Takeaways

• The expiration of patents caused a sharp decline in branded aripiprazole revenues, yet newer formulations and indications provide growth avenues.
• Biosimilar competition and generics dominate current sales, requiring strategic adaptation from original manufacturers.
• Expansion into emerging markets offers substantial growth but demands tailored pricing and regulatory strategies.
• Investment in R&D for long-acting injectables and digital health integrations remains critical to maintaining market relevance.
• The neuropsychiatric drug segment's growth prospects align with broader societal shifts toward mental health awareness and treatment adherence.

FAQs

1. What factors contributed to the decline in aripiprazole’s branded sales?
   Patent expirations and the subsequent influx of generic versions drastically reduced revenue, compressing profit margins for original manufacturers.

2. How are biosimilars impacting the aripiprazole market?
   Biosimilars offer more cost-effective options, challenging branded formulations, especially in price-sensitive markets, influencing overall revenue streams.

3. What are the key regulatory considerations for aripiprazole’s future?
   Regulatory approval of biosimilars varies globally, with strict compliance needed for marketing. Additionally, controlled substance scheduling influences distribution and prescribing practices.

4. Which emerging markets show the most promise for aripiprazole?
   China, India, and Brazil present significant opportunities due to growing healthcare infrastructure, increased mental health awareness, and government initiatives.

5. What innovations could restore growth to aripiprazole's revenue?
   Development of longer-acting injectables, combination therapies, and digital health monitoring tools are promising innovations to enhance adherence and outcomes.

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Sources:
[1] WHO. World Mental Health Reports, 2022.
[2] IQVIA. 2019 Global Pharma Trends Report.
[3] European Medicines Agency. Biosimilar Aripiprazole Approval Notice, 2021.
[4] OECD. Drug Pricing and Reimbursement Policies, 2022.
[5] MarketsandMarkets. Neuropsychiatric Drugs Market Size & Trends, 2023.