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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-nine patent family members in twenty-four 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:	69
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	24
Patent Applications:	55
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 eleven 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	9,174,975*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	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	9,815,827
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	200603-004	Apr 26, 2012	AB	RX	Yes	No	RE45573*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No	8,883,794*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	200603-005	Jul 12, 2013	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	200603-003	Dec 7, 2011	5,532,372*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	200603-005	Jul 12, 2013	9,815,827
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	9,174,975*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:

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

France

Hong Kong

Hungary

Japan

Luxembourg

Mexico

Netherlands

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Taiwan

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
European Patent Office	1944030	Agent de traitement de schizophrénie (Agent for treatment of schizophrenia)
Australia	2006250340	Pharmaceutical composition
Japan	2016094440	精神疾患の治療方法 (METHODS FOR TREATING MENTAL DISEASES)
Taiwan	I359020
Japan	H0517440	NEW IMIDE DERIVATIVE
Canada	2538265	PROCEDE POUR PRODUIRE UN COMPOSE IMIDE (PROCESS FOR PRODUCING IMIDE COMPOUND)

Supplementary Protection Certificates for LATUDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	CR 2014 00049	Denmark		PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
1884242	300690	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1884242	PA2014034	Lithuania		PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321
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	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	C20140030 00118	Estonia		PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014

LATUDA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: LATUDA

Introduction

LATUDA, also known as lurasidone, is an atypical antipsychotic medication used primarily for the treatment of schizophrenia and bipolar depression. Here, we will delve into the market dynamics and financial trajectory of LATUDA, highlighting its key advantages, market trends, and financial performance.

Market Advantages of LATUDA

Efficacy and Safety Profile

LATUDA is distinguished by its strong clinical profile, which includes a lower risk of weight gain and metabolic disturbances compared to other antipsychotics. This favorable side effect profile makes it a preferred choice for many patients and healthcare providers[3].

Dosage and Adherence

The medication is administered once daily, which enhances patient adherence and contributes to treatment success. Its versatility extends to adjunctive therapy in major depressive disorder, aligning with the trend of personalized treatment plans[3].

Competitive Market Position

LATUDA has been positioned competitively in the atypical antipsychotic market, with a strong sales force dedicated to engaging psychiatrists through a multimodal approach. The inclusion of olanzapine as an active control in efficacy studies has further validated its clinical effectiveness[1].

Market Trends

Increasing Awareness of Mental Health

The growing awareness of mental health issues has driven demand for effective treatments like LATUDA. The focus on improved mental well-being and the shift toward patient-centered care have increased the demand for medications that enhance patient quality of life and adherence[3].

Demand for Medications with Fewer Side Effects

The trend toward medications with fewer side effects is prominent, and LATUDA's favorable side effect profile makes it an attractive choice. The growing popularity of telemedicine and digital health platforms has also increased access to mental health services, boosting the demand for LATUDA[3].

Emerging Therapies and Market Competition

The market for bipolar depression is expected to change due to extensive research and incremental healthcare spending. Emerging therapies and late-stage products are anticipated to give tough market competition to LATUDA, influencing its market dominance[4].

Financial Performance

Revenue Trends

The revenue from LATUDA has experienced fluctuations in recent years. In the fiscal year ending March 31, 2023, Sumitomo Pharma reported a decline in revenue from LATUDA, contributing to an overall revenue decrease of 0.8% year-on-year to 555.5 billion yen[2].

Impact of Exclusive Marketing Period Expiration

The expiration of the exclusive marketing period of LATUDA in the U.S. has significantly impacted its sales. Despite this, revenue from LATUDA and other products like ORGOVYX and GEMTESA has grown, partly due to the effects of the forex situation[2].

Core Operating Profit and Expenses

Core operating profit decreased by 72.0% year-on-year to 16.4 billion yen, largely due to an increase in selling, general, and administrative expenses. The North American segment saw a core segment profit decrease by 69.4% year-on-year, attributed to lower gross profit from lower sales[2].

Quarterly Financial Performance

In the first quarter of FY2023, revenues from LATUDA and TWYMEEG increased, but overall revenues declined due to the termination of the Trulicity sales collaboration and other factors. The core operating profit decreased significantly, resulting in an operating loss[5].

Regulatory and Developmental Activities

Clinical Development and Regulatory Milestones

LATUDA's development and regulatory milestones continue to shape its market presence. Detailed descriptions of its mechanism of action, dosage, and administration, as well as ongoing research and developmental activities, are crucial for its market forecast and competitive positioning[4].

Future Market Assessments

The market forecast for LATUDA in bipolar depression indicates that the drug will face competition from emerging therapies. However, its established efficacy and tolerability are expected to maintain its relevance in the market[4].

Key Takeaways

• Strong Clinical Profile: LATUDA's lower risk of weight gain and metabolic disturbances makes it a preferred choice.
• Market Trends: Increasing awareness of mental health and demand for medications with fewer side effects drive its demand.
• Financial Performance: Revenue from LATUDA has declined due to the expiration of its exclusive marketing period, but it remains a significant player.
• Regulatory and Developmental Activities: Ongoing research and developmental activities are crucial for its competitive positioning.

FAQs

Q: What are the primary uses of LATUDA? A: LATUDA is primarily used for the treatment of schizophrenia and bipolar depression, and it is also used as adjunctive therapy in major depressive disorder[3].

Q: What are the key advantages of LATUDA over other antipsychotics? A: LATUDA has a lower risk of weight gain and metabolic disturbances, and its once-daily dosing enhances patient adherence[3].

Q: How has the expiration of the exclusive marketing period affected LATUDA's sales? A: The expiration of the exclusive marketing period in the U.S. has significantly impacted LATUDA's sales, contributing to a decline in revenue[2].

Q: What are the emerging trends in the market for bipolar depression that could impact LATUDA? A: Emerging therapies and late-stage products are expected to give tough market competition to LATUDA, influencing its market dominance[4].

Q: How does LATUDA's financial performance reflect its market position? A: Despite a decline in revenue, LATUDA remains a significant player due to its strong clinical profile and competitive market positioning. However, it faces challenges from increasing competition and higher operational expenses[2][5].

Sources

1. LATUDA Commercial Update - Sumitomo Pharma
2. Consolidated Financial Results for the Year Ended March 31, 2023 - Sumitomo Pharma
3. Lurasidone (Latuda) Manufacturing Plant Project Report 2024 - IMARC Group
4. United States and Japan LATUDA Market Drug Insight and Market Forecast - 2032 - Research and Markets
5. Presentation Q1 Financial Results Briefing for FY2023 - Sumitomo Pharma