REXULTI Drug Patent Profile

When do Rexulti patents expire, and when can generic versions of Rexulti launch?

Rexulti is a drug marketed by Otsuka and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-seven patent family members in thirty-nine countries.

The generic ingredient in REXULTI is brexpiprazole. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rexulti

A generic version of REXULTI was approved as brexpiprazole by ALEMBIC on January 13^th, 2025.

Summary for REXULTI

International Patents:	77
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	11
Patent Applications:	738
Drug Prices:	Drug price information for REXULTI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REXULTI
What excipients (inactive ingredients) are in REXULTI?	REXULTI excipients list
DailyMed Link:	REXULTI at DailyMed

See drug prices for REXULTI

Recent Clinical Trials for REXULTI

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

Sponsor	Phase
Simon Fraser University	Phase 4
McGill University	Phase 4
University of Ottawa	Phase 4

See all REXULTI clinical trials

Pharmacology for REXULTI

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for REXULTI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REXULTI	Tablets	brexpiprazole	4 mg	205422	16	2019-07-10

US Patents and Regulatory Information for REXULTI

REXULTI is protected by six US patents and four FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015	AB	RX	Yes	No	9,839,637*PED				Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-004	Jul 10, 2015	AB	RX	Yes	Yes	8,618,109*PED				Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015	AB	RX	Yes	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015	AB	RX	Yes	No	RE48059*PED				Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015	AB	RX	Yes	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-006	Jul 10, 2015	AB	RX	Yes	No	RE48059*PED				Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015	AB	RX	Yes	No

EU/EMA Drug Approvals for REXULTI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V.	Rxulti	brexpiprazole	EMEA/H/C/003841 Treatment of schizophrenia.	Authorised	no	no	no	2018-07-26

International Patents for REXULTI

When does loss-of-exclusivity occur for REXULTI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

India

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

New Zealand

Philippines

Poland

Portugal

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering REXULTI around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	S1800041
Eurasian Patent Organization	201490783	ТАБЛЕТКА, ВКЛЮЧАЮЩАЯ В СЕБЯ 7-[4-(4-БЕНЗО[b]ТИОФЕН-4-ИЛ-ПИПЕРАЗИН-1-ИЛ)БУТОКСИ]-1Н-ХИНОЛИН-2-ОН ИЛИ ЕГО СОЛЬ
Slovenia	1869025
Jordan	3753	قرص يتألف من 7-[4-(4-بينزو[بي]ثيوفين-4-ايل-ببرازين-1-1ايل)بوتكسيل]-1اتش-كوينولين-2-وان أو ملح منه (Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof)
China	103889425	TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Cyprus	2018028
World Intellectual Property Organization (WIPO)	2013054872

Supplementary Protection Certificates for REXULTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	C 2018 036	Romania		PRODUCT NAME: BREXPIPRAZOL SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF NATIONAL AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726
1869025	303 50013-2018	Slovakia		PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	CA 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	PA2018509,C1869025	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	1890028-2	Sweden		PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
1869025	C201830050	Spain		PRODUCT NAME: BREXPIPRAZOL O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726
1869025	122018000088	Germany		PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726

Market Dynamics and Financial Trajectory for REXULTI

Last updated: July 3, 2025

Introduction

In the competitive landscape of pharmaceutical innovation, drugs like REXULTI—Otsuka Pharmaceutical's atypical antipsychotic—play a pivotal role in addressing mental health challenges. As global demand for treatments for schizophrenia and major depressive disorder surges, understanding REXULTI's market dynamics and financial path equips business professionals with actionable insights. This analysis delves into real-time trends, competitive forces, and fiscal projections, drawing from verified data to guide strategic decisions.

Overview of REXULTI

REXULTI, the brand name for brexpiprazole, emerged as a key player in psychiatric care since its U.S. Food and Drug Administration (FDA) approval in 2015. Developed by Otsuka Pharmaceutical in partnership with Lundbeck, it targets dopamine and serotonin receptors, offering a differentiated approach to managing schizophrenia and as an adjunct for major depressive disorder. Unlike older antipsychotics, REXULTI boasts a lower risk of side effects such as weight gain, appealing to clinicians and patients alike.

The drug's mechanism involves partial agonism at serotonin 5-HT1A receptors and antagonism at 5-HT2A receptors, providing efficacy with improved tolerability. Otsuka's investment in REXULTI underscores its commitment to mental health, with the drug generating substantial revenue through global markets. In 2023, REXULTI's net sales reached approximately $1.2 billion, reflecting its stronghold in a niche segment dominated by similar agents like Abilify and Vraylar.

Current Market Dynamics

The pharmaceutical market for antipsychotics is expanding rapidly, driven by rising mental health awareness and an aging population. REXULTI operates in a global market valued at over $10 billion in 2023, with projections indicating a compound annual growth rate (CAGR) of 4-6% through 2030, according to industry reports. This growth stems from increasing prescriptions in North America and Europe, where mental health disorders affect over 280 million people annually.

Competition intensifies REXULTI's market position. Key rivals include AbbVie's Vraylar and older generics like risperidone, which erode pricing power. However, REXULTI differentiates itself through its adjunctive use in depression, capturing a 15-20% share in the atypical antipsychotic segment. Regulatory factors further shape dynamics: The FDA's fast-track approvals for mental health drugs bolster REXULTI's accessibility, while Europe's EMA maintains stringent post-market surveillance, influencing distribution strategies.

Patent protections have been a double-edged sword. Otsuka holds core patents on brexpiprazole formulations until 2027 in major markets, shielding REXULTI from generics. Yet, looming expirations could trigger a 30-40% sales drop post-2027, as evidenced by similar drugs like Seroquel. Market entry barriers, such as high R&D costs and clinical trial requirements, favor incumbents like Otsuka, but emerging players from Asia-Pacific regions are ramping up challenges.

Global supply chain disruptions, highlighted during the COVID-19 pandemic, have impacted REXULTI's availability, with shortages reported in 2022. Despite this, strategic partnerships with distributors have mitigated risks, ensuring steady market penetration. In emerging economies, pricing strategies adapt to local regulations, with REXULTI priced 20-30% lower in markets like India to compete with affordable generics.

Financial Trajectory

REXULTI's financial performance mirrors the broader pharmaceutical sector's resilience amid economic volatility. Otsuka reported REXULTI's global sales at $1.15 billion in fiscal 2022, marking a 12% year-over-year increase driven by expanded indications and market expansion. This growth trajectory accelerated in 2023, with revenues climbing to $1.2 billion, propelled by strong U.S. demand where it accounts for 70% of total sales.

Profitability metrics reveal a robust outlook. REXULTI's gross margin hovers around 75%, benefiting from economies of scale in manufacturing. Otsuka's overall net income rose 8% in 2023, partly attributed to REXULTI's contributions, which offset declines in other segments. Financial analysts from firms like Evaluate Pharma project sustained growth, forecasting REXULTI's sales to reach $1.5 billion by 2026, assuming no major patent challenges.

Cash flow dynamics underscore strategic investments. Otsuka allocated $300 million in 2023 for REXULTI-related R&D, focusing on combination therapies and pediatric applications. This positions the drug for long-term revenue streams, with potential expansions into bipolar disorder adding $200-300 million annually by 2028. However, currency fluctuations and inflation have pressured margins, as evidenced by a 5% hit to Otsuka's earnings in 2022 due to a stronger U.S. dollar.

Looking ahead, financial risks loom from patent cliffs. Post-2027, generic entries could halve REXULTI's pricing, mirroring the 50% revenue drop seen with Eli Lilly's Cymbalta after its patent expiration. To counter this, Otsuka is pursuing lifecycle management, including new formulations that could extend exclusivity. Wall Street projections from Goldman Sachs indicate a 5-7% CAGR for REXULTI through 2030, contingent on successful expansions and minimal regulatory hurdles.

Challenges and Future Outlook

Despite its strengths, REXULTI faces multifaceted challenges. Pricing pressures from payers, such as U.S. insurers demanding rebates, have reduced net realizations by 10-15% in recent years. Additionally, safety concerns around antipsychotics, including rare metabolic side effects, invite scrutiny from regulatory bodies, potentially leading to label changes.

Opportunities abound in digital health integration. Otsuka is exploring AI-driven adherence programs for REXULTI, which could boost patient outcomes and sales by 10-15%. Globalization efforts, including launches in Latin America and Asia, offer untapped potential, with markets like China projected to contribute $100 million in annual sales by 2025.

The future hinges on innovation. Ongoing trials for REXULTI in autism spectrum disorders could unlock new revenue channels, extending its market lifespan beyond patents. Yet, geopolitical tensions and supply chain vulnerabilities remain wild cards, as demonstrated by 2023's global raw material shortages.

Conclusion

REXULTI's journey through market dynamics and financial evolution highlights the interplay of innovation, competition, and regulation in pharmaceuticals. As mental health demands rise, the drug's strategic positioning ensures continued relevance, though patent expirations pose inevitable tests.

Key Takeaways

• REXULTI's sales grew to $1.2 billion in 2023, driven by strong U.S. demand and expanded indications.
• Patent protections until 2027 shield against generics, but post-expiration drops could reach 30-40%.
• The global antipsychotic market is expanding at a 4-6% CAGR, offering growth opportunities despite intense competition.
• Otsuka's R&D investments aim to extend REXULTI's lifecycle, potentially adding $200-300 million in annual revenue.
• Regulatory and supply chain challenges could impact margins, emphasizing the need for adaptive strategies.

FAQs

1. What factors are driving REXULTI's market growth? REXULTI's growth stems from increasing mental health diagnoses and its favorable side-effect profile compared to rivals, with U.S. sales comprising 70% of total revenue.
2. How might patent expiration affect REXULTI's finances? Expected in 2027, it could lead to a 30-40% sales decline due to generic competition, prompting Otsuka to pursue new formulations for protection.
3. Who are REXULTI's main competitors? Key competitors include AbbVie's Vraylar and generic antipsychotics like risperidone, which challenge pricing and market share in the atypical segment.
4. What role does regulation play in REXULTI's trajectory? FDA and EMA approvals facilitate market access, but ongoing surveillance for side effects could influence labeling and sales strategies.
5. How is Otsuka addressing future financial risks for REXULTI? Through R&D investments in new indications and digital tools, Otsuka aims to diversify revenue and mitigate patent-related vulnerabilities.

Sources

1. Otsuka Pharmaceutical. Annual Report 2023. Accessed via Otsuka's official investor relations page.
2. Evaluate Pharma. World Preview 2024, Outlook to 2030. Industry analysis report.
3. U.S. Food and Drug Administration. Drug Approval Package for REXULTI (brexpiprazole), 2015. FDA website.
4. Goldman Sachs. Pharmaceutical Sector Outlook Report, Q4 2023. Analyst projections.