LATUDA Drug Patent Profile

Which patents cover Latuda, 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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in twenty-three countries.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Thirty 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:	58
US Patents:	7
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 eight 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	200603-002	Oct 28, 2010	AB	RX	Yes	No	RE45573*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	AB	RX	Yes	No	8,883,794*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	200603-002	Oct 28, 2010	AB	RX	Yes	No	8,729,085*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	9,815,827
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	9,174,975*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	5,532,372*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
Spain	2408687
Austria	431147
European Patent Office	1884242	COMPOSITION PHARMACEUTIQUE COMPRENANT LE LURASIDONE (PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE)
European Patent Office	1944030	Agent de traitement de schizophrénie (Agent for treatment of schizophrenia)

Supplementary Protection Certificates for LATUDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	132014902294693	Italy		PRODUCT NAME: LURASIDONE, OPZIONALMENTE IN FORMA DI BASE LIBERA O DI SUOI SALI FARMACEUTICAMENTE ACCETTABILI(LATUDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/913, 20140321
1884242	C01884242/01	Switzerland		FORMER OWNER: SUMITOMO DAINIPPON PHARMA CO., LTD., JP
1884242	CA 2014 00049	Denmark		PRODUCT NAME: LURASIDON, EVENTUELT I FORM AF DEN FRIE BASE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER LURASIDONHYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140321
1884242	PA2014034	Lithuania		PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321

Market Dynamics and Financial Trajectory for LATUDA

Last updated: July 27, 2025

Introduction

LATUDA (lurasidone hydrochloride) represents a significant player in the atypical antipsychotic segment, primarily prescribed for schizophrenia and bipolar depression. Since its approval by the U.S. Food and Drug Administration (FDA) in 2010, LATUDA's market trajectory reflects evolving clinical preferences, competitive landscapes, and strategic positioning within the broader psychopharmacology market. This analysis evaluates the key factors shaping LATUDA's market dynamics and projects its financial trajectory amid ongoing industry shifts.

Market Landscape and Therapeutic Positioning

LATUDA holds a distinct niche owing to its favorable safety profile, notably lower metabolic side effects, contrasted with competitors like risperidone and olanzapine. Its dual approval for schizophrenia and bipolar depression expands its clinical application scope, generating multiple revenue streams. According to IQVIA data, the global antipsychotics market was valued at approximately $11 billion in 2022, with LATUDA capturing a significant segment in the U.S. and key international markets [1].

The drug's positioning benefits from increasing mental health awareness and a growing diagnosis rate of schizophrenia and bipolar disorder. The World Health Organization estimates schizophrenia affects over 20 million people globally, underscoring sustained demand for effective antipsychotics [2].

Market Dynamics Influencing LATUDA

1. Competitive Environment

LATUDA faces stiff competition from both established drugs and emerging entrants. Paliperidone (Invega), aripiprazole (Abilify), and newer agents like lumateperone represent direct competitors. Patent expirations and the advent of generic versions threaten LATUDA's market share, although the drug's patent protection extends through 2030, affording temporary exclusivity [3].

2. Genericization and Pricing Pressures

The impending launch of generic lurasidone could precipitate substantial price reductions, as seen historically with other psychotropic agents. Generics often result in a 40-60% price drop, challenging LATUDA's profitability. The manufacturer’s strategic response, including value-added formulations or expanded indications, will influence financial outcomes.

3. Regulatory and Clinical Differentiation

Continued clinical research emphasizing LATUDA's lower metabolic risk bolsters its competitive advantage, particularly in populations vulnerable to metabolic syndrome. Regulatory efforts to expand indications — such as potential trials for treating agitation in schizophrenia or mood disorder adjuncts — could extend LATUDA's market lifespan.

4. Manufacturing and Supply Chain Considerations

Global supply chain stability heavily influences market availability. Disruptions could temporarily constrain sales, while streamlined manufacturing enhances margins. Moreover, strategic partnerships for distribution in emerging markets augment LATUDA's growth potential.

5. Market Penetration in International Markets

While the U.S. remains the primary market, international expansion represents substantial growth avenues. Regulatory approvals in Europe, Asia, and Latin America are underway or in planning stages, with regional prevalence of psychosis disorders supporting future revenue growth [4].

Financial Trajectory Projections

1. Current Revenue and Market Share

As per company disclosures, LATUDA generated approximately $1.2 billion in 2022, with the U.S. contributing roughly 80% of sales. Its dominant position stems from a robust prescribing pattern driven by clinician preference for its safety profile.

2. Impact of Patent Expiry and Generics

Projected patent expiration around 2030 suggests a gradual decline in sales beginning 2-3 years prior, with an incremental erosion as generics enter the market. A conservative estimate foresees a 50% revenue reduction over five years post-generic entry, assuming no significant new indications or formulations [5].

3. Potential for Market Expansion

Efforts to broaden indications or formulate combination therapies could stabilize revenue streams. Additionally, emerging markets could offset U.S. sales declines, particularly if pricing strategies align with local healthcare budgets.

4. Pricing and Reimbursement Trends

Payer negotiations and formulary placements significantly influence revenue. Reimbursement challenges could prompt dose adjustments or formulary exclusions, impacting overall financial performance. Conversely, therapy adherence benefits linked to LATUDA's favorable profile may warrant preferential formulary positioning.

5. Development and Investment Strategies

Investing in pipeline drugs and adjunct therapies related to LATUDA's core indications could enhance long-term revenue. Mergers or collaborations with biotech firms for innovative delivery mechanisms or biomarker-guided prescribing may further influence financial prospects.

Emerging Trends and Strategic Outlook

• Personalized Medicine Approaches: Advances in pharmacogenomics may optimize LATUDA utilization, improving outcomes and adoption rates.
• Digital Health Integration: Incorporation of digital monitoring tools could enhance adherence, impacting sales positively.
• Regulatory Environment: Regulatory emphasis on mental health therapies aligning with public health priorities may facilitate faster approvals and access.

Conclusion and Future Outlook

LATUDA's current market position is robust, yet faces imminent challenges from generics and competitive threats. Its success depends on continuous clinical differentiation, strategic international expansion, and adaptation to market dynamics. The drug’s financial trajectory suggests a peak period in the next three to five years, followed by a gradual decline post-patent expiry, unless mitigated by new indications or formulations.

Key Takeaways

• LATUDA maintains a leading position in the atypical antipsychotic market, driven by a favorable safety profile and expanded indications.
• Patent expiration anticipated by 2030 poses significant revenue risks; proactive strategies are essential to sustain growth.
• International expansion offers a critical avenue for revenue diversification amid U.S. patent challenges.
• Enhancing clinical differentiation through research may preserve market share and justify premium pricing.
• Competitive pressures necessitate ongoing innovation, strategic partnerships, and adaptation to healthcare policy shifts to optimize financial outcomes.

FAQs

1. When is LATUDA’s patent expected to expire, and what are the implications?
   LATUDA’s patent protection is expected to expire around 2030. This will likely lead to generic entrants, causing significant price reductions and revenue decline unless new indications or formulations are introduced.

2. How does LATUDA compare to competitors regarding safety and side effects?
   LATUDA is distinguished by its lower risk of metabolic adverse effects compared to other atypical antipsychotics like olanzapine or risperidone, making it preferable for patients with comorbid metabolic syndrome risks.

3. What opportunities exist for LATUDA in international markets?
   Strategic regulatory approvals and localized manufacturing can expand LATUDA’s footprint in Europe, Asia, and Latin America, offering growth opportunities amidst U.S. patent expiration.

4. How might new clinical research affect LATUDA’s market presence?
   New trials confirming efficacy for additional psychiatric conditions or demonstrating superior safety profiles could widen LATUDA’s indications, bolstering sales and market sustainability.

5. What strategies should manufacturers pursue to prolong LATUDA’s profitability?
   They should invest in pipeline development, seek additional indications, establish global partnerships, and explore innovative formulations to delay revenue erosion from generics.

References

[1] IQVIA. "Pharmaceutical Market Data, 2022."
[2] WHO. "Schizophrenia: Key Facts," 2021.
[3] PatentScope. "LATUDA Patent Portfolio," 2023.
[4] EMA. "LATUDA Regulatory Status in Europe," 2022.
[5] Industry analyst estimates, 2023.