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Last Updated: July 19, 2025

REXULTI Drug Patent Profile


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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 13th, 2025.

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Drug patent expirations by year for REXULTI
Drug Prices for REXULTI

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Recent Clinical Trials for REXULTI

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

SponsorPhase
Simon Fraser UniversityPhase 4
McGill UniversityPhase 4
University of OttawaPhase 4

See all REXULTI clinical trials

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 8319
Patent: COMPRIMIDO QUE COMPRENDE 7-[4-(4-BENZO[B]TIOFEN-4-IL-PIPERACIN-1-IL)BUTOXI]-1H-QUINOLIN-2-ONA O UNA DE SUS SALES
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 12321723
Patent: Tablet including 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl) butoxy]-1H-quinolin-2-one or salt thereof
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2014008603
Patent: tablete, e, método para produzir um tablete
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 51588
Patent: COMPRIME COMPRENANT DE LA 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OU UN SEL DE CELLE-CI (TABLET COMPRISING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXYL)-1H-QUINOLIN-2-ONE OR A SALT THEREOF)
Estimated Expiration: ⤷  Try for Free

Chile

Patent: 14000909
Patent: Una tableta que comprende 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoxi]-1h-quinolin-2-ona o una sal de ella como ingrediente activo; y metodo para producirla.
Estimated Expiration: ⤷  Try for Free

China

Patent: 3889425
Patent: TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Estimated Expiration: ⤷  Try for Free

Patent: 7397730
Patent: 含有7‑[4‑(4‑苯并[b]噻吩‑4‑基‑哌嗪‑1‑基)丁氧基]‑1H‑喹啉‑2‑酮或其盐的片剂 (TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 50480
Patent: Tableta que contiene 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoxi]-1h-quinolin-2-ona o una de sus sales
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0200037
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 22460
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 67285
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 2930
Patent: ТАБЛЕТКА, ВКЛЮЧАЮЩАЯ В СЕБЯ 7-[4-(4-БЕНЗО[b]ТИОФЕН-4-ИЛ-ПИПЕРАЗИН-1-ИЛ)БУТОКСИ]-1Н-ХИНОЛИН-2-ОН ИЛИ ЕГО СОЛЬ (TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF)
Estimated Expiration: ⤷  Try for Free

Patent: 1490783
Patent: ТАБЛЕТКА, ВКЛЮЧАЮЩАЯ В СЕБЯ 7-[4-(4-БЕНЗО[b]ТИОФЕН-4-ИЛ-ПИПЕРАЗИН-1-ИЛ)БУТОКСИ]-1Н-ХИНОЛИН-2-ОН ИЛИ ЕГО СОЛЬ
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 67285
Patent: COMPRIMÉ COMPRENANT DE LA 7-[4-(4-BENZO[b]THIOPHÉN-4-YL-PIPÉRAZIN-1-YL) BUTOXY]-1H-QUINOLÉIN-2-ONE OU UN SEL DE CELLE-CI (TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF)
Estimated Expiration: ⤷  Try for Free

Finland

Patent: 67285
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 47493
Estimated Expiration: ⤷  Try for Free

India

Patent: 55DEN2014
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 1513
Patent: טבליה הכוללת 7-[4-(4-בנזו[b]תיאופן-4-איל-פיפראזין-1-איל)בוטוקסי]-1h-קינולין-2-און או מלח שלו (Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1h-quinolin-2-one or salt thereof)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 2013054872
Patent: 7−[4−(4−ベンゾ[b]チオフェン−4−イル−ピペラジン−1−イル)ブトキシ]−1H−キノリン−2−オン又はその塩を含む錠剤
Estimated Expiration: ⤷  Try for Free

Patent: 84161
Estimated Expiration: ⤷  Try for Free

Patent: 17088610
Patent: 7−[4−(4−ベンゾ[b]チオフェン−4−イル−ピペラジン−1−イル)ブトキシ]−1H−キノリン−2−オン又はその塩を含む錠剤 (TABLET CONTAINING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
Estimated Expiration: ⤷  Try for Free

Jordan

Patent: 53
Patent: 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)
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 67285
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 3370
Patent: TABLET COMPRISING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 6092
Patent: TABLETA QUE COMPRENDE 7-[4-(4-BENZO[B]TIOFEN-4-IL-PIPERAZIN-1-IL)BUTOXI]-1H-QUINOLIN-2-ONA O SAL DE LA MISMA. (TABLET INCLUDING 7-[4-(4-BENZO[ï1⁄2 ]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
Estimated Expiration: ⤷  Try for Free

Patent: 14004135
Patent: TABLETA QUE COMPRENDE 7-[4-(4-BENZO[B]TIOFEN-4-IL-PIPERAZIN-1-IL)B UTOXI]-1H-QUINOLIN-2-ONA O SAL DE LA MISMA. (TABLET INCLUDING 7-[4-(4-BENZO[ï1⁄2 ]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF.)
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 2639
Patent: Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl) butoxy]-1h-quinolin-2-one or a salt thereof
Estimated Expiration: ⤷  Try for Free

Philippines

Patent: 014500607
Patent: TABLET COMPRISING 7-[4-(4-BENZO[B]THIOPEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 67285
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 67285
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 14013783
Patent: TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Estimated Expiration: ⤷  Try for Free

Patent: 201608412S
Patent: TABLET COMPRISING 7-[4-(4-BENZO[ b ]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 67285
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 1402333
Patent: TABLET INCLUDING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN -1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 2072371
Estimated Expiration: ⤷  Try for Free

Patent: 140075754
Patent: TABLET INCLUDING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 62479
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 34908
Estimated Expiration: ⤷  Try for Free

Patent: 1318651
Patent: Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 4411
Patent: ТАБЛЕТКА, ЩО МІСТИТЬ 7-[4-(4-БЕНЗО[b]ТІОФЕН-4-ІЛ-ПІПЕРАЗИН-1-ІЛ)БУТОКСИ]-1H-ХІНОЛІН-2-ОН АБО ЙОГО СІЛЬ (TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
Estimated Expiration: ⤷  Try for Free

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 ⤷  Try for Free
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 ⤷  Try for Free
Slovenia 1869025 ⤷  Try for Free
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) ⤷  Try for Free
China 103889425 TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF ⤷  Try for Free
Cyprus 2018028 ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2013054872 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REXULTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 C 2018 036 Romania ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025 CA 2018 00028 Denmark ⤷  Try for Free PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025 PA2018509,C1869025 Lithuania ⤷  Try for Free PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 1890028-2 Sweden ⤷  Try for Free PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
1869025 C201830050 Spain ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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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.