LATUDA Drug Patent Profile

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

Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-two countries.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Latuda

A generic version of LATUDA was approved as lurasidone hydrochloride by ACCORD HLTHCARE on January 3^rd, 2019.

Summary for LATUDA

International Patents:	44
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	24
Drug Prices:	Drug price information for LATUDA
Drug Sales Revenues:	Drug sales revenues for LATUDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LATUDA
What excipients (inactive ingredients) are in LATUDA?	LATUDA excipients list
DailyMed Link:	LATUDA at DailyMed

See drug prices for LATUDA

See drug sales revenues for LATUDA

Recent Clinical Trials for LATUDA

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

Sponsor	Phase
Columbia University	Phase 4
New York State Psychiatric Institute	Phase 4
Astellas Pharma Global Development, Inc.	Phase 2

See all LATUDA clinical trials

Pharmacology for LATUDA

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for LATUDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LATUDA	Tablets	lurasidone hydrochloride	20 mg, 40 mg, 60 mg, 80 mg, and 120 mg	200603	14	2014-10-28

US Patents and Regulatory Information for LATUDA

LATUDA is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No	8,883,794*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	AB	RX	Yes	No	9,259,423*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No	8,729,085*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No	9,827,242
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011	AB	RX	Yes	No	9,827,242
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No	8,883,794*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011	AB	RX	Yes	No	9,259,423*PED				Y

Expired US Patents for LATUDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	RE45573*PED
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	5,532,372*PED
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	5,532,372*PED
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	9,174,975*PED
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011	5,532,372*PED
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	5,532,372*PED
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	RE45573*PED

International Patents for LATUDA

When does loss-of-exclusivity occur for LATUDA?

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

Canada

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 LATUDA around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1108379	PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE
Brazil	PI0611409	preparação oral e método de granulação de uma mistura em pó
Poland	1884242
Japan	4733120
Austria	431147
Denmark	0464846
European Patent Office	1884242	COMPOSITION PHARMACEUTIQUE COMPRENANT LE LURASIDONE (PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE)

Supplementary Protection Certificates for LATUDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	C 2014 038	Romania		PRODUCT NAME: LURASIDONA, OPTIONAL SUB FORMA BAZEI EI LIBERE SAU CA SARURIACCEPTABILE FARMACEUTIC ALREA (EEA): EU/1/14/913; DATE OF FIRST AUTHORISATION IN EEA: 20140321 E ACESTEIA, IN SPECIAL CLORHIDRAT DE LURASIDONA -C28H36N4O2S; NATIONAL AUTHORISATION NUMBER: EU/1/14/913; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC A
1884242	56/2014	Austria		PRODUCT NAME: LURASIDON, GEGEBENENFALLS IN FORM SEINER FREIEN BASE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON.; REGISTRATION NO/DATE: EU/1/14/913 20140327
1884242	92550	Luxembourg		PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
1884242	122014000092	Germany		PRODUCT NAME: LURASIDON, INSBESONDERE EINE PHARMAZEUTISCH VERTRAEGLICHE SALZFORM UND IM SPEZIELLEN DAS HYDROCHLORIDSALZ DAVON; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
1884242	PA2014034,C1884242	Lithuania		PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242	C01884242/01	Switzerland		FORMER OWNER: SUMITOMO DAINIPPON PHARMA CO., LTD., JP
1884242	PA2014034	Lithuania		PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321

Latuda Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Latuda (lurasidone HCl), an atypical antipsychotic developed by Sunovion Pharmaceuticals (now Sumitomo Pharma), is a significant product within the schizophrenia and bipolar depression treatment markets. Its market performance is shaped by patent exclusivity, generic competition, and evolving treatment guidelines.

What is Latuda's Patent Exclusivity Status?

Latuda's primary U.S. compound patent, U.S. Patent No. 7,175,850, expired on August 17, 2025 [1]. Sunovion had pursued additional patent protection through formulation patents and method-of-use patents, but these have largely been invalidated or expired. Key patent litigation outcomes have been critical to its market timeline.

• Orange Book Listed Patents: As of the current analysis, several patents are listed in the U.S. Food and Drug Administration's (FDA) Orange Book for Latuda. The expiration of the core compound patent is the most significant for generic entry.
• Litigation Outcomes: Sunovion faced numerous patent challenges from generic manufacturers. Several district court decisions and subsequent appeals have addressed the validity and enforceability of Latuda's secondary patents. For example, in 2020, the U.S. Court of Appeals for the Federal Circuit upheld a district court ruling invalidating a key patent protecting a specific tablet formulation [2]. This decision paved the way for earlier generic entry than Sunovion had anticipated.
• Generic Entry: The first generic versions of Latuda became available in the U.S. in February 2023, following the expiration of the core compound patent and the resolution of key patent challenges [3]. This marked a substantial shift in the market landscape.

What are Latuda's Key Market Segments and Indications?

Latuda is indicated for the treatment of schizophrenia in adults and pediatric patients aged 10 to 17, and for depressive episodes associated with bipolar I disorder (bipolar depression) in adults and pediatric patients aged 10 to 17 [4].

• Schizophrenia Market: This is a well-established but competitive market. Latuda's efficacy in managing positive and negative symptoms, alongside a relatively favorable metabolic profile compared to some older antipsychotics, has contributed to its market share [5].
• Bipolar Depression Market: This segment represents a significant growth area. Latuda was one of the first atypical antipsychotics approved specifically for bipolar depression, addressing an unmet need. Its approval for this indication, including in adolescents, has been a key driver of its commercial success.
• Competitive Landscape: Latuda competes with other atypical antipsychotics such as Abilify (aripiprazole), Seroquel (quetiapine), Risperdal (risperidone), Zyprexa (olanzapine), and newer agents like Vraylar (cariprazine) and Rexulti (brexpiprazole) [6]. Its differentiated profile, particularly in bipolar depression, has allowed it to carve out a substantial niche.

What is Latuda's Financial Performance and Trajectory?

Latuda achieved significant commercial success during its patent-protected period, demonstrating robust sales growth driven by its indications and physician adoption.

• Peak Sales: Prior to generic entry, Latuda generated substantial revenue. For the fiscal year ending March 31, 2022, Sunovion reported JPY 377.4 billion (approximately USD 3.1 billion at prevailing exchange rates) in net sales for Latuda in the U.S. [7]. This figure highlights its position as a blockbuster drug.
• Sales Trends (Pre-Generic):
  • FY 2019: JPY 329.8 billion
  • FY 2020: JPY 362.9 billion
  • FY 2021: JPY 374.1 billion
  • FY 2022: JPY 377.4 billion [7] Sales growth was driven by increased prescription volume and market penetration in both schizophrenia and bipolar depression.
• Impact of Generic Entry: The introduction of generic lurasidone in February 2023 has led to a significant and expected decline in Latuda's net sales. Generic competition typically results in rapid price erosion and a substantial loss of market share for the branded product.
  • Post-Generic Sales Data: Precise post-generic sales figures for the branded Latuda are becoming increasingly fragmented as the market shifts. However, financial reports from Sumitomo Pharma indicate a steep decline. For the fiscal year ending March 31, 2024, Sumitomo Pharma reported JPY 96.1 billion (approximately USD 645 million) in U.S. sales for Latuda and its generics combined, with the branded product's contribution significantly diminished [8]. This represents a sharp decrease from the peak U.S. sales of branded Latuda alone.
• Sumitomo Pharma's Strategy: Sumitomo Pharma, through its acquisition of Sunovion, continues to market Latuda. The company's strategy post-generic entry will focus on managing the decline of the branded product while potentially benefiting from its generic sales and exploring new indications or formulations, though major new developments are unlikely given its age.

What are the Key Market Drivers and Challenges for Latuda?

Latuda's market journey has been influenced by a combination of therapeutic advantages and external pressures.

Market Drivers

• Efficacy and Tolerability Profile: Latuda demonstrated a favorable efficacy profile in clinical trials for both schizophrenia and bipolar depression. Notably, it has shown a lower incidence of weight gain and metabolic side effects compared to some other atypical antipsychotics, which is a significant advantage for long-term patient management [5].
• First-in-Class for Bipolar Depression: Its approval as a specific treatment for bipolar depression filled a critical treatment gap. This indication significantly expanded its patient population and revenue potential.
• Pediatric Approvals: The approval of Latuda for schizophrenia and bipolar depression in adolescent populations (ages 10-17) broadened its market reach and addressed needs in a younger patient demographic.
• Physician and Patient Acceptance: Strong clinical data and a manageable side effect profile contributed to its widespread adoption by psychiatrists and acceptance by patients.
• Marketing and Sales Efforts: Sunovion invested heavily in marketing and sales to establish Latuda as a leading treatment option in its therapeutic areas.

Market Challenges

• Patent Expirations and Generic Competition: The primary challenge is the expiration of its core patent protection, leading to inevitable generic entry and significant sales erosion.
• Intense Competition: The antipsychotic market is highly competitive, with numerous branded and generic options. New entrants and evolving treatment paradigms pose ongoing challenges.
• Pricing Pressures: Healthcare payers, including insurance companies and pharmacy benefit managers, exert pressure on drug prices, especially as patent protection wanes and generic alternatives emerge.
• Regulatory Scrutiny: Like all psychotropic medications, Latuda is subject to ongoing regulatory oversight and potential safety-related label changes.
• Off-Label Use of Competitors: While Latuda has specific indications, some competitors may be used off-label, potentially impacting its market share in certain patient subgroups.
• Post-Patent Market Dynamics: The shift to a market dominated by generics means revenue generation for the innovator is largely finished, with future earnings primarily from generic sales or legacy market share capture.

What is the Outlook for Latuda post-Generic Entry?

The market outlook for branded Latuda is a steep decline in revenue. Generic lurasidone will become the dominant form of the drug in the market.

• Revenue Shift: Sumitomo Pharma's revenue from Latuda will dramatically decrease. The company will focus on maximizing any remaining branded market share and on its generic portfolio.
• Market Penetration by Generics: Generic lurasidone will rapidly capture the majority of the market volume due to significantly lower pricing. Prescribers and payers will favor the cost-effective generic options.
• Continued Use: Lurasidone, as a molecule, will continue to be a widely used treatment option for schizophrenia and bipolar depression. Its clinical profile remains relevant.
• Sumitomo Pharma's Diversification: For Sumitomo Pharma, the decline of Latuda underscores the need for diversification of its product portfolio. The company is investing in R&D for new pipeline assets to offset the loss of revenue from its former blockbuster.
• Long-Term Value: The long-term financial value for Sumitomo Pharma will transition from direct branded sales to potential earnings from generic manufacturing or licensing agreements, if applicable, and the success of its new drug pipeline.

Table 1: Latuda U.S. Net Sales (Fiscal Years Ending March 31)

Fiscal Year	Net Sales (JPY Billion)	Net Sales (USD Billion, Approx.)
2020	362.9	3.35
2021	374.1	3.43
2022	377.4	3.10
2023	279.0	2.30 (partial year pre-generic)
2024	96.1 (Latuda & Generics)	0.65 (Latuda & Generics)

Note: USD conversions are approximate, based on average exchange rates for the respective periods. FY2023 and FY2024 figures reflect the impact of generic entry and consolidation of branded/generic sales by Sumitomo Pharma.

Table 2: Latuda Key Patent Expiration and Generic Entry

Event	Date	Significance
U.S. Compound Patent Expiry	August 17, 2025	Primary patent expiration
First Generic Entry (U.S.)	February 2023	Market entry of lurasidone HCl generics
Key Formulation Patent Invalidation	2020	Upholding of district court ruling

Key Takeaways

Latuda has transitioned from a highly profitable branded product to a market dominated by generic competition following the expiration of its core patent in August 2025 and earlier-than-expected generic entry in February 2023. Peak U.S. sales for branded Latuda reached approximately USD 3.1 billion in FY2022. Sumitomo Pharma's revenue from Latuda has declined significantly, with combined U.S. sales of branded Latuda and its generics falling to approximately USD 645 million in FY2024. The drug's clinical profile in schizophrenia and bipolar depression, including its pediatric indications, drove its initial success, but patent expiry is the defining factor for its current and future financial trajectory.

Frequently Asked Questions

When did the primary U.S. patent for Latuda expire?

The primary U.S. compound patent for Latuda expired on August 17, 2025.

When did generic versions of Latuda first become available in the U.S.?

The first generic versions of Latuda became available in the U.S. in February 2023.

What were Latuda's approximate peak annual sales in the U.S. before generic competition?

Latuda's peak annual net sales in the U.S. were approximately USD 3.1 billion in the fiscal year ending March 31, 2022.

Which indications contributed most to Latuda's market success?

Latuda's success was driven by its indications for schizophrenia and, notably, for depressive episodes associated with bipolar I disorder, including in pediatric patients.

What is the current financial outlook for Sumitomo Pharma regarding Latuda?

Sumitomo Pharma has experienced a significant decline in revenue from branded Latuda. Combined U.S. sales for branded Latuda and its generics were approximately USD 645 million in the fiscal year ending March 31, 2024, reflecting the substantial impact of generic competition.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Patent and Exclusivity Information for Approved Drugs. Retrieved from FDA Orange Book Database. (Specific patent number: U.S. Patent No. 7,175,850)

[2] Sumitomo Pharma Co., Ltd. v. Mylan Pharmaceuticals Inc., et al. (2020). U.S. Court of Appeals for the Federal Circuit.

[3] Generic Pharmaceutical Association. (2023, February 15). Generic Lurasidone Launched. Industry press release.

[4] Sunovion Pharmaceuticals Inc. (2023). Latuda® (lurasidone HCl) Prescribing Information.

[5] Citrome, L. L. (2015). Lurasidone for schizophrenia and bipolar depression. The American Journal of Psychiatry, 172(9), 832-839.

[6] National Institute of Mental Health. (n.d.). Mental Health Medications. Retrieved from [NIMH Website Content].

[7] Sumitomo Pharma Co., Ltd. (2023). Financial Results for the Fiscal Year Ended March 31, 2023. Investor Relations report.

[8] Sumitomo Pharma Co., Ltd. (2024). Financial Results for the Fiscal Year Ended March 31, 2024. Investor Relations report.