Lurasidone hydrochloride - Generic Drug Details

What are the generic sources for lurasidone hydrochloride and what is the scope of patent protection?

Lurasidone hydrochloride is the generic ingredient in two branded drugs marketed by Sunovion Pharms Inc, Accord Hlthcare, Adaptis, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, 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. Twenty-nine 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:	29
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	79
Patent Applications:	122
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
First Affiliated Hospital of Zhejiang University	Phase 4
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Phase 4
NeuroRx, Inc.	Phase 2/Phase 3

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
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No	8,729,085*PED				Y
Watson Labs Teva	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208016-001	Feb 2, 2021		DISCN	No	No
Amneal Pharms Co	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208002-003	Jan 3, 2019	AB	RX	No	No
Macleods Pharms Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	212124-005	Jun 9, 2023	AB	RX	No	No
Invagen Pharms	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208028-002	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	200603-003	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	200603-004	Apr 26, 2012	9,815,827
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	200603-002	Oct 28, 2010	9,174,975*PED

International Patents for lurasidone hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	101380088
Japan	WO2005009999	イミド化合物の製造方法
Japan	4610485
Brazil	PI0611409	preparação oral e método de granulação de uma mistura em pó
Hong Kong	1108379	PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE

Supplementary Protection Certificates for lurasidone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C300690	Netherlands		PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242	C01884242/01	Switzerland		FORMER OWNER: SUMITOMO DAINIPPON PHARMA CO., LTD., JP
1884242	SPC/GB14/063	United Kingdom		PRODUCT NAME: LURASIDONE HYDROCHLORIDE; REGISTERED: UK EU/1/14/913/001 20140327; UK EU/1/14/913/002 20140327; UK EU/1/14/913/003 20140327; UK EU/1/14/913/004 20140327; UK EU/1/14/913/005 20140327; UK EU/1/14/913/006 20140327; UK EU/1/14/913/007 20140327; UK EU/1/14/913/008 20140327; UK EU/1/14/913/009 20140327; UK EU/1/14/913/010 20140327; UK EU/1/14/913/011 20140327; UK EU/1/14/913/012 20140327; UK EU/1/14/913/013 20140327; UK EU/1/14/913/014 20140327; UK EU/1/14/913/015 20140327; UK EU/1/14/913/016 20140327; UK EU/1/14/913/017 20140327; UK EU/1/14/913/018 20140327; UK EU/1/14/913/019 20140327; UK EU/1/14/913/020 20140327; UK EU/1/14/913/021 20140327
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

Market Dynamics and Financial Trajectory for Lurasidone Hydrochloride Tablets

Introduction

Lurasidone hydrochloride, marketed as Latuda, is an antipsychotic medication primarily used to treat schizophrenia and bipolar depression. The market for lurasidone hydrochloride tablets is experiencing significant growth, driven by several key factors. Here, we will delve into the market dynamics and financial trajectory of this drug.

Increasing Prevalence of Mental Health Disorders

The rising incidence of schizophrenia and bipolar disorder worldwide is a primary driver of the lurasidone hydrochloride tablets market. These conditions are becoming more prevalent, and the need for effective treatment options is increasing, thereby boosting the demand for lurasidone hydrochloride[1].

Growing Awareness and Destigmatization of Mental Health

The growing awareness and destigmatization of mental health issues are contributing to the increased adoption of lurasidone hydrochloride tablets. As more people seek medical help for mental health disorders, the market for these tablets is expanding[1].

Expanding Healthcare Infrastructure

The expanding healthcare infrastructure and rising healthcare expenditure in developing countries are enhancing access to psychiatric care. This improvement in healthcare access is a significant factor driving the growth of the lurasidone hydrochloride tablets market[1].

Ongoing Research and Development

Ongoing research and development in psychopharmacology are leading to improved formulations and treatment protocols. This continuous innovation supports the market growth by providing better treatment options for patients with mental health disorders[1].

Demographic Factors

The growing geriatric population, who are more prone to psychiatric conditions, further drives the demand for lurasidone hydrochloride tablets. Additionally, the rising urban population, especially in urban centers, is propelling the demand due to the heightened need for specific aspects provided by these tablets[1].

Regional Market Analysis

North America

North America is a significant player in the global lurasidone hydrochloride tablets market, with the United States and Canada being major contributors. The region benefits from a robust economy, technological advancements, and a strong consumer base with high purchasing power[1].

Europe

Europe is another major region, comprising countries such as the United Kingdom, Germany, France, and Italy. The region is characterized by a mature market with well-established infrastructure and consumer preferences[1].

Asia-Pacific

The Asia-Pacific region is rapidly growing, driven by countries such as China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization in this region are leading to greater demand for lurasidone hydrochloride tablets[1].

Latin America

Latin America presents opportunities and challenges, with countries like Brazil, Mexico, and Argentina being key players. Economic fluctuations and political instability in some countries can impact market dynamics and consumer behavior[1].

Middle East and Africa

The Middle East and Africa represent emerging markets, with countries like UAE, Saudi Arabia, South Africa, and Nigeria showing promising growth potential. Economic diversification efforts, urbanization, and a young population are driving demand in the region[1].

Financial Trajectory

Market Size and Growth

The lurasidone hydrochloride tablets market is expected to grow significantly, with a valuation projected to reach USD 81.69 billion by 2031 from USD 37.32 billion in 2024. This growth is anticipated at a compound annual growth rate (CAGR) of 11.84% from 2024 to 2031[1].

Revenue and Sales

Companies like Sunovion Pharmaceuticals, which markets lurasidone as Latuda, have seen substantial revenue growth. For instance, Sunovion aimed to reach $1 billion in sales for Latuda in North America, highlighting the drug's commercial success[2].

Cost and Gross Profit

The financial performance of companies involved in the lurasidone hydrochloride market is robust, with significant gross profits. For example, Sunovion's financial reports show substantial gross profits and operating incomes, driven by the sales of Latuda[2].

Strategic Consolidation and Innovation

Mergers and Acquisitions

The market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. These strategic moves provide access to new technologies, intellectual property, and talent, enabling companies to innovate faster and stay ahead of market trends[1].

Access to New Technologies

Acquisitions provide companies with access to new technologies, which is crucial for the development of improved formulations and treatment protocols. This continuous innovation supports the market growth by providing better treatment options for patients[1].

Impact on Comorbidities

Lurasidone has been praised for its relative safety, especially its lack of adverse cardiometabolic effects. This aspect is particularly beneficial for patients with comorbidities, as it reduces the risk of additional health complications. For instance, data presented by Henry Chung, MD, and Joseph Calabrese, MD, highlighted the drug's benefits in reducing episodes of depression and associated healthcare costs[3].

Key Takeaways

• The lurasidone hydrochloride tablets market is driven by the increasing prevalence of mental health disorders, growing awareness, and expanding healthcare infrastructure.
• The market is expected to grow significantly, reaching USD 81.69 billion by 2031.
• Regional markets such as North America, Europe, and Asia-Pacific are key contributors to the market's growth.
• Strategic consolidation through mergers and acquisitions is a significant factor in market growth.
• Lurasidone's safety profile, particularly its lack of adverse cardiometabolic effects, is a major advantage.

FAQs

What is the current market size and future growth prospects of the Lurasidone Hydrochloride Tablets market?

The Lurasidone Hydrochloride Tablets market is anticipated to grow from USD 37.32 billion in 2024 to USD 81.69 billion by 2031, at a CAGR of 11.84%[1].

What are the primary drivers of the Lurasidone Hydrochloride Tablets market?

The primary drivers include the increasing incidence of schizophrenia and bipolar disorder, growing awareness and destigmatization of mental health issues, expanding healthcare infrastructure, and ongoing research and development in psychopharmacology[1].

Which regions are significant players in the global Lurasidone Hydrochloride Tablets market?

North America, Europe, and the Asia-Pacific region are significant players, with the Middle East and Africa representing emerging markets[1].

How does lurasidone hydrochloride impact comorbidities?

Lurasidone hydrochloride is praised for its relative safety, especially its lack of adverse cardiometabolic effects, which is beneficial for patients with comorbidities and reduces associated healthcare costs[3].

What role do mergers and acquisitions play in the Lurasidone Hydrochloride Tablets market?

Mergers and acquisitions help companies consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness, providing access to new technologies and talent[1].

Sources

1. Lurasidone Hydrochloride Tablets Market Size, Share - openPR.com
   • https://www.openpr.com/news/3628569/lurasidone-hydrochloride-tablets-market-size-share
2. Financial Results for FY2014 (The year ended March 31, 2015) - Sumitomo Pharma
   • https://www.sumitomo-pharma.com/ir/library/presentation/assets/pdf/eir20150511_1.pdf
3. Lurasidone's Effect on Comorbidities Explored - AJMC
   • https://www.ajmc.com/view/lurasidones-effect-on-comorbidities-explored