LURASIDONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for lurasidone hydrochloride and what is the scope of freedom to operate?

Lurasidone hydrochloride is the generic ingredient in two branded drugs marketed by Sunovion Pharms Inc, Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Heritage Pharma Avet, Invagen Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in twenty NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lurasidone hydrochloride has fifty-eight patent family members in twenty-three countries.

There are twenty-six drug master file entries for lurasidone hydrochloride. Thirty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LURASIDONE HYDROCHLORIDE

International Patents:	58
US Patents:	7
Tradenames:	2
Applicants:	20
NDAs:	20
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	81
Patent Applications:	311
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LURASIDONE HYDROCHLORIDE
What excipients (inactive ingredients) are in LURASIDONE HYDROCHLORIDE?	LURASIDONE HYDROCHLORIDE excipients list
DailyMed Link:	LURASIDONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LURASIDONE HYDROCHLORIDE

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

Sponsor	Phase
University Health Network, Toronto	PHASE1
Centre for Addiction and Mental Health	PHASE1
Massachusetts General Hospital	PHASE4

See all LURASIDONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		120MG	TABLET;ORAL
		80MG	TABLET;ORAL
		60MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LURASIDONE HYDROCHLORIDE

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for LURASIDONE HYDROCHLORIDE

Adrenergic alpha-2 Receptor Antagonists

Antipsychotic Agents

Dopamine D2 Receptor Antagonists

Serotonin 5-HT2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for LURASIDONE HYDROCHLORIDE

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LURASIDONE HYDROCHLORIDE

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 LURASIDONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Annora Pharma	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	218174-002	Aug 21, 2024	AB	RX	No	No
Amneal Pharms Co	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208002-004	Jan 3, 2019	AB	RX	No	No
Torrent	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208055-002	Jan 3, 2019	AB	RX	No	No

Expired US Patents for LURASIDONE HYDROCHLORIDE

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

International Patents for LURASIDONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	6470164
Japan	4610485
China	101184489	Pharmaceutical composition

Supplementary Protection Certificates for LURASIDONE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2014 00049	Denmark		PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
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 Lurasidone Hydrochloride

Last updated: July 27, 2025

Introduction

Lurasidone hydrochloride is an atypical antipsychotic medication primarily approved for the treatment of schizophrenia and bipolar disorder. Since its launch, it has gained prominence due to its efficacy and favorable side-effect profile, positioning itself amid a competitive landscape of schizophrenia therapies. This analysis examines the evolving market dynamics, revenue trajectory, and strategic considerations influencing Lurasidone’s financial outlook.

Market Overview

Growing Demand for Atypical Antipsychotics

The global market for antipsychotics, particularly atypical (second-generation) agents, has experienced robust growth driven by increased diagnosis and awareness of mental health disorders. In 2021, the global antipsychotic drugs market was valued at approximately USD 14 billion and projected to grow at a compound annual growth rate (CAGR) of over 3% through 2028 [1]. The demand is buoyed by the recognition of schizophrenia’s lifelong impact, alongside increased access to psychiatric services.

Competitor Landscape

Lurasidone’s primary competitors include drugs such as risperidone, olanzapine, quetiapine, aripiprazole, and newer agents like cariprazine. The competitive edge of lurasidone stems from its favorable side effect profile, notably lower metabolic and weight gain issues, which influence prescribing patterns.

Regulatory and Market Access Factors

Lurasidone was first approved by the FDA in 2013 for schizophrenia and subsequently for bipolar depression. Its intellectual property rights and patent protection (expired in some markets) influence generic entry timelines, affecting revenue streams. Payers increasingly favor drugs with proven safety profiles, impacting market penetration.

Market Dynamics

Patent Expiry and Generic Competition

The expiration of patents in major markets such as the U.S. and Europe is imminent or has already transpired, opening pathways for generic competitors. Generic entry typically results in significant price erosion—up to 70–80%—and reduced profit margins for branded manufacturers [2]. Consequently, the revenue trajectory post-patent expiry generally follows a sharp decline unless offset by increased volume sales or expanded indications.

Pricing and Reimbursement Trends

Healthcare payers — including government agencies and insurers — are increasingly scrutinizing drug prices, favoring cost-effective therapies. Lurasidone’s favorable side effect profile may translate into cost savings regarding metabolic side effect management, strengthening its reimbursement prospects. However, generic competition pressures prices downward.

Market Penetration and Prescriber Preferences

Prescriber preference hinges on efficacy, tolerability, and formulary inclusion. Lurasidone’s association with improved metabolic outcomes has facilitated its uptake within patients requiring long-term management, such as those with comorbid metabolic syndrome.

Geographic Expansion and Indication Expansion

While initial approvals focused on schizophrenia, recent label expansions include bipolar depression. Expanding indications and geographic reach into emerging markets, where mental health awareness is increasing, may unlock additional revenue streams. However, regulatory hurdles and pricing pressures in these regions can temper growth prospects.

Financial Trajectory

Revenue Outlook in Patent-Protected Phase

During patent exclusivity, lurasidone’s revenues exhibit steady growth, driven by increased prescriptions and expanding indications. The drug’s market share within atypical antipsychotics tends to stabilize around 10–15% globally, with higher shares in North America due to early adoption and favorable prescribing habits.

Post-Patent Erosion and Generic Competition

Following patent expiry, revenues are expected to decline sharply—potentially by 50–80% within 2-3 years unless digital health strategies, line extensions, or new formulations are introduced. Companies often offset this decline via increased volume sales, especially in emerging markets, or through launches of new formulations and adjuncts.

Strategic Initiatives Impacting Financials

Innovative formulations such as depot injections, combinations, or long-acting injectables may mitigate revenue erosion by creating differentiated products. Additionally, pipeline drugs or biosimilars could supplement revenue streams, enhancing financial stability.

Investment and R&D Considerations

Ongoing R&D efforts in establishing new indications or optimizing existing formulations contribute to future revenue streams. Licensing partnerships and acquisitions also influence the financial landscape, offering potential growth avenues.

Market Risks and Opportunities

Risks

• Patent Litigation and Patent Cliff: Threat of generic entry and patent challenges can accelerate revenue decline.
• Market Saturation: Limited scope for further market share expansion once slow-growing or established prescriber habits dominate.
• Pricing Pressures: Rising focus on biosimilars and value-based pricing models compress profit margins.

Opportunities

• Expanded Indications: Exploring conditions like treatment-resistant schizophrenia or adjunctive therapies.
• Digital Therapeutics and Adherence Technologies: Improving treatment compliance can expand market size.
• Emerging Market Penetration: Growing healthcare infrastructure enhances adoption potential.

Conclusion

Lurasidone hydrochloride’s market dynamics are characterized by a classic lifecycle susceptible to patent expiration and generic competition. While its current revenue trajectory benefits from clinical advantages and expanding indications, sustainability hinges upon strategic differentiation, pipeline innovation, and geographic expansion. Stakeholders should monitor regulatory developments, market access reforms, and prescriber adoption patterns to inform investment decisions.

Key Takeaways

• Patent expiration prospects will significantly influence future revenues, necessitating strategic diversification.
• Generic competition will exert downward pressure on pricing, impacting profit margins.
• Clinical profile advantages can sustain market share and foster brand loyalty, especially in focus markets.
• Pipeline development and indication expansion remain crucial to offset revenue erosion post-patent expiry.
• Emerging markets offer growth opportunities, provided regulatory and reimbursement landscapes are navigated effectively.

FAQs

1. When is the patent for lurasidone hydrochloride set to expire in key markets?
Patent expiries vary by jurisdiction; in the U.S., primary patents have faced expiration around 2021–2022, with secondary patents possibly extending exclusivity in certain markets. However, patent challenges and regulatory data exclusivities can influence timelines.

2. What are the main differentiators of lurasidone compared to other atypical antipsychotics?
Lurasidone offers a lower risk of metabolic side effects, such as weight gain and diabetes, which improves adherence and long-term tolerability compared to agents like olanzapine or quetiapine.

3. How might generic entry impact the revenue trajectory of lurasidone?
Generic entry typically causes substantial price erosion and volume-based competition, leading to a decline in branded drug revenues, often within 1–3 years post-patent expiry.

4. Are there emerging indications that could extend the market for lurasidone?
Research into adjunctive therapies for conditions such as treatment-resistant schizophrenia or bipolar disorder could potentially expand its therapeutic scope, pending regulatory approval.

5. What strategic measures can pharmaceutical companies implement to sustain revenues with lurasidone?
Developing novel formulations, seeking new indications, pursuing geographic expansion, leveraging digital health tools, and engaging in licensing agreements are key strategies.

---

References

[1] Grand View Research. (2022). Antipsychotic Drugs Market Size, Share & Trends.
[2] IQVIA. (2021). Global Pharmaceutical Pricing & Reimbursement Report.