rexulti Drug Patent Profile

Which patents cover Rexulti, and what generic alternatives are available?

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. Three 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
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 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
Taiwan	I634908
Portugal	2767285
Cyprus	2018028
Netherlands	300946
Denmark	2767285

Supplementary Protection Certificates for rexulti

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	CA 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	2018/034	Ireland		PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1294 20180726; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2402)
1869025	CR 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
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: February 19, 2026

What is REXULTI and its approved uses?

REXULTI (brexiprazole) is an atypical antipsychotic developed by Otsuka Pharmaceutical Co. and Lundbeck. It received U.S. FDA approval in July 2015 for:

• Schizophrenia in adults
• Adjunctive treatment for major depressive disorder (MDD) in adults

It is marketed in the U.S. and globally, with a focus on mental health indications.

How does REXULTI perform in its target markets?

Market Size and Demographics

• The global schizophrenia market is projected to reach $12.8 billion by 2027, expanding at a compound annual growth rate (CAGR) of 3.2% from 2020.
• The depression market, specifically MDD, is valued at approximately $12 billion in 2022 with a CAGR of 1.8% through 2027.

Market Penetration and Competition

• REXULTI's market penetration remains limited relative to peers such as Abilify (aripiprazole), Seroquel (quetiapine), and Latuda (lurasidone).
• Its market share in the U.S. for schizophrenia is reported at less than 8% as of 2022.
• Competition from generic formulations of older antipsychotics and newer medications like Vraylar (cariprazine) pressures pricing and market share growth.

What are the key drivers of REXULTI's market performance?

Clinical Profile and Efficacy

• REXULTI offers a differentiated side effect profile with a lower risk of metabolic syndrome, weight gain, and extrapyramidal symptoms.
• Efficacy in reducing symptoms of schizophrenia and MDD has been validated in clinical trials, but head-to-head comparisons favor some competitors.

Reimbursement and Pricing

• Pricing for REXULTI in the U.S. averages around $750 per month.
• Reimbursement policies vary; coverage is generally favorable but less so than older, generic drugs.
• Price competition with generics and biosimilars limits revenue growth potential.

Market Awareness and Prescriber Adoption

• REXULTI's awareness remains low outside specialist centers.
• Adoption is slower in primary care versus psychiatric specialists.
• Pharma outreach efforts target psychiatrists, with limited expansion into primary care settings.

How are revenues trending?

Year	Revenue (USD millions)	Growth Rate
2020	150	N/A
2021	165	+10%
2022	180	+9%

• Revenue growth reflects modest gains driven by increased prescriptions in targeted patient populations.
• Market share expansion remains constrained by competition, pricing dynamics, and prescriber hesitancy.

What financial risks influence REXULTI's trajectory?

Patent and Exclusivity

• U.S. composition of matter patent expired in 2023, with data exclusivity expected to last until 2028.
• Patent cliff exposes REXULTI to generic entry, risking significant revenue declines.

Investment in R&D and Marketing

• Otsuka and Lundbeck have invested heavily in clinical trials and marketing.
• Continued R&D is focused on new indications and formulations, which could impact costs and future revenue streams.

Regulatory and Pricing Environment

• Stricter pricing regulations and reimbursement pressures in key markets like the U.S. and Europe.
• Any adverse regulatory decisions or label updates could impact market access and revenue.

What is the outlook for REXULTI’s financial performance?

• Revenue is expected to grow at a low single-digit CAGR through 2027, barring major market share shifts.
• Increased competition from generics could erode profits over the next 3-5 years.
• Expansion into additional indications like bipolar disorder or autism spectrum disorders remains under evaluation, with uncertain commercial impact.

Key Takeaways

• REXULTI operates in a competitive, slow-growth segment with stable but limited uptake.
• Market share remains constrained by high pricing, slow prescriber adoption, and generics.
• Revenues are experiencing modest increases, but patent expiration risks pose long-term threats.
• Financial trajectory hinges on gaining broader prescriber acceptance, securing additional indications, and managing competitive pressures.

FAQs

1. When is REXULTI facing generic competition?

Patent for the formulation expired in 2023; generics are expected to enter the U.S. market starting late 2023 or early 2024.

2. What are the primary competitors to REXULTI?

Abilify (aripiprazole), Latuda (lurasidone), and Vraylar (cariprazine) are its main competitors, all with broader market shares and established prescriber bases.

3. Can REXULTI be used off-label for other indications?

While off-label use is common in psychiatry, currently, REXULTI has only FDA approval for schizophrenia and as adjunct therapy for MDD, limiting off-label prescribing.

4. What is the potential for REXULTI's revenue growth?

Limited to low single-digit CAGR given competition, pricing pressures, and patent expiry. Growth hinges on new indication approvals and prescriber acceptance.

5. Are there upcoming regulatory reviews for REXULTI?

No major regulatory reviews are publicly scheduled beyond ongoing post-marketing studies; future label updates depend on new clinical trial data.

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References

[1] U.S. Food and Drug Administration. (2015). FDA approves brexiprazole (REXULTI) for schizophrenia [Press release].

[2] GlobalData. (2022). Schizophrenia market forecast.

[3] IQVIA. (2022). Prescription data for antipsychotics according to market share.

[4] Statista. (2022). Market size and growth projections for depression drugs.

[5] Otsuka Pharmaceutical Co., Ltd. Annual Report 2022.