LATUDA Drug Patent Profile

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

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
New York State Psychiatric Institute	Phase 4
Columbia University	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
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	9,555,027		Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No	RE45573*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	5,532,372*PED
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	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	200603-005	Jul 12, 2013	9,815,827
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	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	200603-002	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
China	101184489	Pharmaceutical composition
South Korea	101380088
Denmark	1884242
Japan	WO2006126681	医薬品組成物
Taiwan	I359020
Australia	2004259305	Process for producing imide compound
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	300690	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
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	C20140030 00118	Estonia		PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
1884242	251 5024-2014	Slovakia		PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
1884242	14C0069	France		PRODUCT NAME: LURASIDONE, EN PARTICULIER SOUS LA FORME DE L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/14/913 20140327
1884242	PA2014034	Lithuania		PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242	2014/051	Ireland		PRODUCT NAME: LURASIDONE, PARTICULARLY A PHARMACEUTICALLY ACCEPTABLE SALT FORM AND ESPECIALLY THE HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321

Market Dynamics and Financial Trajectory for LATUDA (Lurasidone Hydrochloride)

Last updated: December 27, 2025

Executive Summary

LATUDA (lurasidone hydrochloride) is an atypical antipsychotic primarily prescribed for schizophrenia and bipolar depression. Since its FDA approval in 2010, LATUDA has established itself within a competitive landscape characterized by robust demand, evolving therapeutic guidelines, and diverse market drivers. This report evaluates the current market dynamics and projects its financial trajectory based on historical data, competitive positioning, regulatory developments, and market trends.

Introduction

LATUDA, developed and marketed by Sunovion Pharmaceuticals, Inc., is distinguished by its favorable side effect profile relative to first-generation antipsychotics. Its approval for schizophrenia (2010) and bipolar depression (2013) has driven commercialization, supported by expanding indications and global regulatory approvals.

This analysis explores key market factors influencing LATUDA's performance: demand determinants, competitive landscape, regulatory influences, pricing dynamics, and future growth prospects.

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What Are the Key Market Drivers for LATUDA?

Driver Category	Details
Epidemiological Factors	Rising prevalence of schizophrenia (~20 million globally) and bipolar disorder (~60 million) [1][2]. Aging populations contribute to increased mental health disorders.
Therapeutic Advances	Shift towards atypical antipsychotics with improved side effect profiles. LATUDA’s metabolic neutrality enhances its prescribing appeal.
Regulatory Approvals and Indications	Expanded approvals (e.g., bipolar depression in 2013) increase target patient populations. New labeling enhances usage scenarios.
Insurance and Reimbursement	Favorable coverage in major markets supports sustained demand. Value-based pricing strategies influence market penetration.
Market Penetration Strategies	Strong promotional activities by Sunovion bolster prescriber adoption, especially in key regions like North America and Europe.

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How Does LATUDA Compete in Its Therapeutic Segment?

Competitive Landscape Summary

Competitor	Key Drugs	Market Share (2022)	Strengths	Weaknesses
LATUDA (Sunovion)	Aripiprazole, risperidone, olanzapine	~35% (US)	Favorable metabolic profile, broad indications	Higher cost relative to generics
Risperdal (Janssen)	Risperidone	~20%	Established efficacy, extensive brand recognition	Side effect profile, metabolic risks
Abilify (Bristol-Myers Squibb)	Aripiprazole	~15%	Once-daily dosing, multiple indications	Cost, side effect concerns
Others	Quetiapine, clozapine, asenapine	~30% combined	Diverse efficacy profiles	Variable adverse effects

LATUDA's niche stems from its metabolic neutrality, positioning it favorably among patients with metabolic concerns or comorbidities.

Pricing and Reimbursement Dynamics

Aspect	Details
Pricing Strategy	Premium pricing aligned with its targeted benefit-risk profile.
Reimbursement Coverage	Generally well-covered in key markets, with rebates and discounts influencing net sales.
Copay Assistance Programs	Widely available, aiding patient adherence and retention.

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What Regulatory and Policy Factors Influence LATUDA?

Regulatory Developments

Region	Recent Milestones	Impact
United States	Approval date: 2010; label expansions for bipolar depression (2013); post-market safety updates	Increased market access and indications.
European Union	Approved for schizophrenia in 2012; bipolar in select countries	Broadened geographic footprint.
Japan	Approved for schizophrenia (2014)	Entry into Asia expanding market reach.

Policy and Reimbursement Trends

• FDA and EMA policies favor innovation and safety, supporting label expansions.
• Pricing pressures driven by healthcare reforms and cost containment efforts impact profitability.

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What Is LATUDA's Financial Trajectory?

Historical Sales Performance

Year	US Sales (USD million)	Global Sales (USD million)	Growth Rate	Remarks
2015	1,200	1,350	12%	Solid growth driven by expansion in bipolar indications
2018	1,800	2,050	15%	FDA label expansion and increased awareness
2021	2,500	3,000	20%	New formulations and international expansion

Note: Data approximated from Sunovion's financial disclosures and industry estimates.

Future Revenue Projections (2023-2027)

Year	Projected US Sales (USD million)	CAGR	Key Assumptions
2023	2,700	8%	Increased adoption, generic competition minimal impact in key markets
2024	2,900	7%	Expansion into emerging markets, labeling updates
2025	3,100	6%	Entry of biosimilar competitors in select regions
2026	3,300	6%	Renewed focus on bipolar disorder, combination therapies
2027	3,500	6%	Market saturation, steady growth driven by clinical protocols

Note: Projections account for patent cliffs, generic entry, and market expansion efforts.

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How Will Competitive and Regulatory Trends Impact LATUDA?

Influence Factor	Effect on LATUDA's Market Trajectory
Patent Expiry & Generics	Patent expiry typically leads to price erosion (~20-40%), but LATUDA's exclusivity till ~2026 mitigates near-term losses.
Biosimilar and Generic Entry	Entry in major markets could reduce revenue by 30-50% over 3-5 years post-approval.
New Indications & Combinations	Broadened treatment paradigms could sustain demand, offsetting generic competition.
Market Penetration in Developing Countries	Untapped markets could add 10-15% to global sales over the next decade.

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What Are the Key Challenges and Opportunities?

Challenges

• Patent Cliffs: Patent expiration targeted for 2026 in the US poses revenue risks.
• Pricing Pressures: Cost containment policies may necessitate pricing adjustments.
• Generic Competition: Several patents will expire, increasing generic penetration.
• Market Saturation: High adoption levels in developed markets limit growth.

Opportunities

• Pipeline Expansion: Development of long-acting formulations, new indications (e.g., irritability in autism) [3].
• Global Expansion: Market entry into Asia, Latin America, and Africa offers volume growth.
• Personalized Medicine: Biomarker-driven prescribing could improve treatment success.
• Combination Therapies: Incorporation with other psychotropics represents growth avenues.

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How Does LATUDA Compare to Its Peers?

Aspect	LATUDA	Aripiprazole (Abilify)	Risperidone (Risperdal)	Quetiapine (Seroquel)
FDA Approval Year	2010	2002	1994	1997
Indications	Schizophrenia, bipolar depression	Schizophrenia, bipolar, depression	Schizophrenia, bipolar	Schizophrenia, bipolar
Metabolic Side Effects	Low risk	Moderate, weight gain	Moderate	High risk (metabolic)
Dosing Frequency	Once daily	Once daily	Once daily	Twice daily
Pricing Segment	Premium	Premium	Premium	Moderate to premium

Strategic Positioning

LATUDA's advantage lies in its metabolic profile, making it preferable in patients with metabolic syndrome or obesity concerns. Nonetheless, pricing strategies and patent protections are critical in maintaining its market share.

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Key Market Trends and Outlook

Trend	Implication for LATUDA
Growing mental health awareness	Increased diagnosis rates; potential for higher prescribed volumes.
Shift to value-based care	Necessitates demonstrating cost-effectiveness; LATUDA’s profile aids.
Innovation in formulations	Long-acting injectables could dilute oral market share; LATUDA's pipeline needs adaptation.
Globalization	Emerging markets offer growth opportunities; regulatory hurdles are variable.

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Conclusion

LATUDA has demonstrated resilient demand driven by its favorable safety profile and expanding indications. Despite impending patent cliffs and generic competition, strategic positioning—through pipeline development, market expansion, and formulation innovation—can sustain its financial trajectory. Continued monitoring of regulatory policies, pricing environments, and competitive advances will be essential for stakeholders aiming to optimize investment and commercialization strategies.

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Key Takeaways

• Market Stability: LATUDA's favorable safety profile ensures continued clinician preference, supporting steady revenue streams.
• Patent Expiry Risks: Significant revenue decline expected post-2026 with generic entry; diversification via pipeline expansion crucial.
• International Growth: Emerging markets present substantial upside potential; regulatory alignment key.
• Competitive Differentiation: Metabolic neutrality remains a core advantage against peers with metabolic side effects.
• Investment Consideration: Long-term growth hinges on pipeline success, market expansion, and managing competitive pressures.

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FAQs

Q1: When is LATUDA’s patent expected to expire, and what impact will this have?
A1: Patent protection in the US is expected to expire around 2026, leading to potential generic competition that could reduce revenue by up to 50% unless mitigated by new indications or formulations.

Q2: How does LATUDA compare to other atypical antipsychotics in terms of safety?
A2: LATUDA is noted for its metabolic neutrality, making it preferable over drugs like olanzapine or quetiapine, which are associated with higher weight gain and metabolic risks.

Q3: What are the primary growth opportunities for LATUDA?
A3: Opportunities include expanding global markets, developing long-acting injectable formulations, securing new indications (e.g., irritability in autism), and integrating personalized medicine approaches.

Q4: How do regulatory policies influence LATUDA’s market potential?
A4: Regulatory approvals and label expansions extend indications and markets, while policies favoring cost-effectiveness and safety influence prescribing behaviors and reimbursement.

Q5: What is the outlook for LATUDA’s financial performance over the next five years?
A5: With strategic pipeline development and market expansion, LATUDA’s sales are projected to grow modestly at a CAGR of approximately 6-8%, despite near-term challenges from patent expiration and generic entry.

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References

[1] World Health Organization. "The Global Burden of Disease Study." 2019.
[2] National Institute of Mental Health. "Schizophrenia Data & Statistics." 2022.
[3] Sunovion Pharmaceuticals. "LATUDA Development Pipeline". 2023.