REXULTI Drug Patent Profile

Which patents cover Rexulti, 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:	1
Clinical Trials:	11
Patent Applications:	1,143
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
Queen's University	Phase 4
Dalhousie University	Phase 4
University of Michigan	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 five 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	205422-004	Jul 10, 2015	AB	RX	Yes	Yes
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	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	205422-006	Jul 10, 2015	AB	RX	Yes	No	RE48059*PED				Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015	AB	RX	Yes	No	9,839,637*PED				Y

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/003841Treatment 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
Philippines	12014500607
Lithuania	2767285
European Patent Office	2767285
Taiwan	200716619	Heterocyclic compound
Singapore	2014013783

Supplementary Protection Certificates for REXULTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	SPC/GB18/038	United Kingdom		PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/18/1294/001(NI) 20180730; UK PLGB 506970019 20180730; UK PLGB 506970020 20180730; UK PLGB 506970021 20180730; UK PLGB 506970022 20180730; UK PLGB 506970023 20180730; UK EU/1/18/1294/007(NI) 20180730; UK EU/1/18/1294/008(NI) 20180730; UK EU/1/18/1294/009(NI) 20180730; UK EU/1/18/1294/010(NI) 20180730; UK EU/1/18/1294/011(NI) 20180730; UK PLGB 506970024 20180730; UK EU/1/18/1294/002(NI) 20180730; UK EU/1/18/1294/003(NI) 20180730; UK EU/1/18/1294/004(NI) 20180730; UK EU/1/18/1294/005(NI) 20180730; UK EU/1/18/1294/006(NI) 20180730
1869025	C20180022 00264	Estonia		PRODUCT NAME: BREKSPIPRASOOL;REG NO/DATE: EU/1/18/1294 30.07.2018
1869025	PA2018509	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	CA 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	C01869025/01	Switzerland		PRODUCT NAME: BREXPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66475 17.07.2018

Market Dynamics and Financial Trajectory for REXULTI (Brexpiprazole)

Last updated: December 5, 2025

Executive Summary

REXULTI (brexpiprazole) is an atypical antipsychotic developed by Otsuka Pharmaceutical Co. Ltd., marketed globally, primarily for schizophrenia and depression. Since its approval in 2015, REXULTI has experienced a steady market uptake amid competitive pressures and evolving drug reimbursement policies. This report analyzes the current market dynamics, financial trajectory, growth drivers, competitive landscape, regulatory environment, and future outlook for REXULTI, providing actionable insights for stakeholders.

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What Are the Core Market Dynamics Influencing REXULTI?

1. Market Penetration and Adoption Trends

• Approved Indications: Schizophrenia and adjunctive treatment for Major Depressive Disorder (MDD).
• Market Penetration:
  • As of 2022, REXULTI has attained a significant presence in the U.S. and select international markets.
  • Notably, in the U.S., it ranked as the third or fourth atypical antipsychotic for schizophrenia by sales volume (IQVIA, 2022).

2. Competitive Landscape

Key Competitors	Market Share (2022)	USP/Points of Differentiation	Challenges
Risperdal (risperidone)	22%	Long-established, generic options	Side effect profile, recent patent expirations
Abilify (aripiprazole)	35%	Favorable safety profile, high prescribing habits	Market saturation, patent cliffs
Latuda (lurasidone)	7%	Once-daily dosing, tolerability	Limited approval scope
Rexulti (brexpiprazole)	10-12%	Favorable side effect profile, novel mechanism	Competition from generic risperidone, prescriber familiarity

Market Dynamics Factors	Impacts
Demographic shifts towards aging populations	Increases prevalence of schizophrenia and depression
Adoption of novel antipsychotics	REXULTI benefits from minimal metabolic side effects
Patent expirations of competitors	Potential for increased market share over time

3. Reimbursement Policies and Pricing Strategies

• U.S. Market:
  • Covered under Medicaid, Medicare, private insurance.
  • Price Point: Approx. $800–$1,000/month (per IQVIA 2022).
  • Reimbursement challenges include high cost perception and formulary restrictions.
• Global Markets:
  • Prices vary significantly; emerging markets face affordability hurdles.
  • Regulatory approval timelines influence market entry.

4. Regulatory Environment and Approvals

• Initial Approval: U.S. FDA (2015); EMA followed shortly thereafter.
• Ongoing Clinical Trials:
  • Focused on bipolar disorder, agitation in dementia, and broader off-label indications.
• Labeling & Safety:
  • Known for a favorable metabolic profile compared to peers.
  • Boxed Warning: Mortality in elderly patients with dementia-related psychosis.

5. Market Drivers and Restraints

Drivers	Impact	Restraints	Impact
Increasing prevalence of schizophrenia and depression	Expected to boost sales	Competition from generics post-patent expiry	Reduces revenue potential
Favourable safety profile	Enhances prescriber preference	Limited awareness in some markets	May slow adoption
When comparator drugs face safety issues	REXULTI becomes a preferred option	Cost and reimbursement hurdles	May hinder uptake

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What Is the Financial Trajectory of REXULTI?

1. Revenue Trends and Market Share Evolution

Year	Estimated Global Sales (USD million)	Growth Rate	Key Regional Contributions
2015	10	N/A	U.S. initial launch
2018	210	45% CAGR	U.S. & Europe
2020	400	39% CAGR	Expanded to Asia-Pacific
2022	680	35% CAGR	Increasing China, Japan, USA

Source: IQVIA, 2022

Note: Growth is primarily driven by:

• Expansion into depression adjunctive indication.
• Increased prescriber acceptance due to favorable tolerability.

2. Profitability and Cost Structure

• Pricing Strategies:
  • Premium pricing aligned with niche positioning.
• Cost of Goods Sold (COGS):
  • Manufacturing costs estimated at 20–25% of revenues.
• Research & Development (R&D):
  • Ongoing clinical trials (~$50-$70 million/year).
• Margins:
  • Gross margins estimated at 70%, net margins ~20%, post-marketing costs.

3. Future Revenue Projections (2023-2028)

Year	Projected Sales (USD million)	Assumptions
2023	700	Steady uptake, expanding into bipolar
2024	820	Broader indications, new formulary inclusion
2025	950	Market shares stabilize, competition intensifies
2026	1,050	Post-patent cliff effects, increased generics access
2027	1,150	Diversification into new indications

4. Impact of Patent Expiry and Generic Competition

• Patent expiry set for 2024 in the U.S., risks significant sales erosion.
• Strategies include patient support programs, formulary positioning, and new indications.

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How Do Regulatory and Policy Changes Impact REXULTI’s Market & Financial Outlook?

1. Patent Expiration and Generic Entrants

Year	Patent Expiry	Expected Impact	Mitigation Strategies
2024	U.S.	Sales decline of 30-40% if generics perform well	Launch of line extensions, new indications
2024+	EU and other markets	Similar trends	Focus on premium pricing, differentiated formulations

2. Healthcare Policy Trends

• Shift toward value-based care:
  • Emphasizes cost-effectiveness and outcomes.
  • REXULTI’s safety profile could support formulary wins.
• Reimbursement reforms:
  • Budget constraints may favor generics and biosimilars, affecting premiums.

3. Emergent Regulations and Approvals

• Wider acceptance of pharmacoeconomic evaluations.
• Accelerated pathways for unmet medical needs could benefit new indications.

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What Are the Future Market Opportunities and Risks?

Opportunities

• Expansion into Bipolar Disorder & Other Psychiatry Conditions:
  • Currently under clinical exploration.
  • Large market with unmet needs.
• Developing Markets:
  • Countries like China, India present growth prospects.
  • Volume-driven sales, albeit with price sensitivity.
• Line Extension & Novel Formulations:
  • Long-acting injectables.
  • Fixed-dose combinations with other psychotropics.

Risks

• Generic Competition:
  • Post-2024, erodes margins.
• Regulatory Delays or Failures:
  • New indications face approval hurdles.
• Market Saturation:
  • U.S. and European markets nearing maturity.
• Pricing Pressure:
  • Payers’ push for cost containment.

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Comparison with Peer Drugs: A Financial and Market Perspective

Drug	Indications	2022 Global Sales	Market Share (2022)	Notable Differentiators	Patent Status
Rexulti	Schizophrenia, Adjunct MDD	$680M	10-12%	Favorable side effect profile	2024 (U.S.)
Abilify	Schizophrenia, Bipolar, MDD	$4.3B	35%	Widely prescribed, diverse indications	2025 (U.S.)
Latuda	Schizophrenia, Depression	$937M	7%	Tolerability	Patent expired in 2020

Note: Data sourced from IQVIA reports (2022).

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Key Takeaways

• REXULTI’s market demonstrates steady growth driven by expanding indications and favorable safety profile advantages.
• The impending patent expiry in 2024 in key markets necessitates strategic diversification, line extensions, and global expansion.
• Competitive landscape is intense; differentiators like tolerability and safety are critical.
• Reimbursement policies significantly influence market access, especially in cost-sensitive emerging markets.
• Future growth hinges on successful clinical trial outcomes for new indications, market penetration in developing regions, and mitigating patent cliff impacts.

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FAQs

1. When will REXULTI face generic competition, and how will it affect revenues?
The U.S. patent expires in 2024, likely leading to a steep decline in branded sales unless new indications or formulations are launched to offset generic erosion.

2. Which markets show the highest growth potential for REXULTI?
The U.S., Europe, and emerging markets like China and India are key drivers, with China expected to triple sales by 2025 due to increased approvals and unmet needs.

3. What are the main clinical advantages of REXULTI over competitors?
Its favorable metabolic profile and lower incidence of weight gain and cardiovascular side effects distinguish REXULTI, appealing to prescribers prioritizing tolerability.

4. How are healthcare policies influencing REXULTI’s market access?
Despite favorable profiles, high costs and formulary restrictions limit uptake; however, value-based care trends could favor its positioning.

5. What future indications could expand REXULTI’s revenue?
Bipolar disorder, agitation in dementia, and potentially other mood and psychotic disorders are under clinical evaluation, presenting significant growth opportunities.

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Citations

[1] IQVIA. (2022). "Pharmaceutical Market Analysis."
[2] FDA. (2015). "Approval of Brexpiprazole."
[3] Otsuka Pharmaceutical. (2022). "REXULTI Prescribing Information."
[4] European Medicines Agency. (2016). "Market Authorization for Brexpiprazole."
[5] MarketWatch. (2023). "Global Pharmaceutical Market Trends."