LUSUTROMBOPAG - Generic Drug Details

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

Lusutrombopag is the generic ingredient in one branded drug marketed by Vancocin Italia and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lusutrombopag has forty-one patent family members in twenty countries.

Two suppliers are listed for this compound.

Summary for LUSUTROMBOPAG

International Patents:	41
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	6
What excipients (inactive ingredients) are in LUSUTROMBOPAG?	LUSUTROMBOPAG excipients list
DailyMed Link:	LUSUTROMBOPAG at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LUSUTROMBOPAG

Constraining patent/regulatory exclusivity:

9,427,402

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LUSUTROMBOPAG

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

Sponsor	Phase
Anhui Provincial Hospital	PHASE2
Peking Union Medical College Hospital	PHASE4
Institute of Hematology & Blood Diseases Hospital, China	PHASE2

See all LUSUTROMBOPAG clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LUSUTROMBOPAG

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

US Patents and Regulatory Information for LUSUTROMBOPAG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes	8,889,722		Y	Y
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes	8,530,668		Y	Y
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes	9,427,402		Y

Expired US Patents for LUSUTROMBOPAG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018	7,601,746

EU/EMA Drug Approvals for LUSUTROMBOPAG

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Shionogi B.V.	Mulpleo (previously Lusutrombopag Shionogi)	lusutrombopag	EMEA/H/C/004720Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures	Authorised	no	no	no	2019-02-18

International Patents for LUSUTROMBOPAG

Country	Patent Number	Title	Estimated Expiration
China	103393678
China	103396313
China	101809008
South Korea	101849808
Japan	WO2012043709	難溶性薬物の溶解性改善製剤
Japan	WO2009017098

Supplementary Protection Certificates for LUSUTROMBOPAG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2184279	2019/039	Ireland		PRODUCT NAME: LUSUTROMBOPAG, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/18/1348 20190218
2184279	C201930048	Spain		PRODUCT NAME: LUSUTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/01/18/1348; DATE OF AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/01/18/1348; DATE OF FIRST AUTHORISATION IN EEA: 20190218
2184279	CR 2019 00038	Denmark		PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220
2184279	1990035-6	Sweden		PRODUCT NAME: LUSUTROMBOPAG; REG. NO/DATE: EU/1/18/1348 20190220
2184279	19C1043	France		PRODUCT NAME: LUSUTROMBOPAG, UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI OU UN SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1348 20190220
2184279	132019000000090	Italy		PRODUCT NAME: LUSUTROMBOPAG(LUSUTROMBOPAG SHIONOGI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1348, 20190220

Market Dynamics and Financial Trajectory for LUSUTROMBOPAG

Last updated: July 28, 2025

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Introduction

Lusutrombopag, marketed under the tradename Havaryu® in Japan, is a recombinant thrombopoietin receptor agonist developed by Shionogi & Co. Ltd. Approved primarily for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) scheduled for invasive procedures, lusutrombopag holds a strategic position within the hematology and hepatology segments. Its market trajectory combines clinical demand, evolving regulatory landscapes, competitive positioning, and the broader economic environment affecting pharmaceutical R&D and commercialization.

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Market Overview

Therapeutic Indication and Unmet Needs

Thrombocytopenia complicates interventions in patients with CLD, particularly those awaiting invasive procedures such as biopsies or surgeries. Traditionally managed via platelet transfusions, which carry risks like alloimmunization and infection, there is a regulatory and clinical impetus for alternative therapies with better safety and convenience profiles. Lusutrombopag addresses these unmet needs by stimulating endogenous platelet production, reducing reliance on transfusions (1).

Market Size and Growth Drivers

The global thrombocytopenia treatment market, estimated to reach approximately USD 2.58 billion by 2026 (2), is driven by increasing prevalence of liver cirrhosis and liver-related comorbidities. The Asian market, notably Japan and China, dominates due to higher CLD burdens, aging populations, and proactive healthcare policies favoring innovative treatments.

In Japan, where lusutrombopag is approved, the market for thrombopoietin receptor agonists has experienced rapid growth, reflecting broader trends toward targeted, oral therapies. The Asia-Pacific region's expansion is further boosted by improvements in healthcare infrastructure and increasing awareness among clinicians, fostering market acceptance.

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Market Dynamics Influencing Lusutrombopag

Competitive Landscape

Lusutrombopag's primary competitors include eltrombopag and avatrombopag, both oral thrombopoietin receptor agonists approved for similar indications. The competitive positioning hinges on factors such as efficacy profiles, side-effect incidence, dosing regimens, and regulatory approvals.

Eltrombopag (Promacta®/Revolade®), developed by GSK, enjoys global approval but has limitations such as hepatotoxicity at higher doses. Avatrombopag (Doptelet®), developed by Dova Pharmaceuticals, offers a similar profile with certain advantages in administration and safety (3). These dynamics influence Lusutrombopag's adoption, especially in regions where competition is fierce.

Regulatory Environment

Regulatory approval pathways impact the trajectory significantly. Japan's approval in 2018 facilitated early market entry but subsequent approvals globally are contingent on demonstrating safety and efficacy. The evolving regulatory standards, especially related to safety monitoring and post-marketing surveillance, can both hinder and propel market entry.

Furthermore, the absence of broad indications outside thrombocytopenia related to liver disease limits the growth potential but also enables focused commercialization efforts within its approved scope.

Pricing and Reimbursement

Pricing strategies are instrumental. Japan's national health insurance coverage for Lusustrombopag (4) has facilitated adoption, but reimbursement policies vary internationally. Cost-effectiveness analyses, demonstrating reduction in transfusion needs and hospital stay durations, bolster favorable reimbursement decisions.

In high-GDP Asian countries, favorable reimbursement policies accelerate uptake, whereas in emerging markets, price sensitivity constrains sales.

Clinical Adoption and Physician Preferences

Physician familiarity, clinical guidelines, and perceived safety profiles influence uptake. As more real-world data accumulates validating lusutrombopag’s safety and efficacy, clinical confidence grows, propelling market penetration.

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Financial Trajectory Analysis

Revenue Trends

Since its approval, lusutrombopag has demonstrated a steady revenue increase within Japan, with estimated sales exceeding USD 100 million in the first two years post-launch (5). The drug’s revenue stream is projected to grow at a CAGR of approximately 15-20% over the next five years, driven by new regional approvals and expanded indications.

Global sales remain nascent but show potential as regulatory approvals expand. The recent application filings in China and recent submissions in South Korea suggest near-term market entry, potentially adding USD 50-80 million annually within Asia alone.

Research and Development Expenditures

Investment in R&D, including Phase III trials and post-marketing studies, exceeds USD 200 million, reflective of Shionogi’s strategic commitment. Like other niche therapies, continuous investment is essential for maintaining efficacy profiles, monitoring safety, and expanding indications.

Profitability and Cost Structures

Gross margins for lusutrombopag are estimated at 70-80%, typical for branded oral specialty drugs, once manufacturing scale is achieved. Marketing, distribution, and regulatory compliance constitute significant expenses, especially when expanding into new markets.

Operational costs are inversely proportional to sales volume; as sales scale increase, per-unit costs decrease, enhancing profitability prospects.

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Key Market Challenges

• Pricing pressure: Competitive landscape and payor scrutiny could pressure pricing, impacting margins.
• Regulatory hurdles: Stringent safety and efficacy requirements in Western markets may delay approvals or restrict indications.
• Market saturation in Japan: Since initial success, the Japanese market faces saturation risks, necessitating geographic expansion.
• Limited indications: Narrow approval scope constrains revenue growth potential, emphasizing regional expansion.

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Opportunities for Growth

• Expansion into new geographies: China, South Korea, and Southeast Asia represent significant growth avenues.
• Broadened indications: Potential approval for thrombocytopenia in other contexts, such as chemotherapy-induced thrombocytopenia, could diversify revenue streams.
• Combination therapies: Integration with other liver disease treatments could enhance clinical utility and market penetration.
• Real-world evidence (RWE) generation: Demonstrating cost savings and safety benefits heightens payer confidence, bolstering reimbursement.

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Conclusion

Lusutrombopag’s market trajectory is shaped by regional adoption rates, competitive dynamics, and evolving healthcare paradigms emphasizing personalized, safety-efficient therapies. Its financial outlook remains promising within niche indications, assuming geographic expansion and indication broadening.

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Key Takeaways

• Lusutrombopag’s success hinges on continuous regional expansion, especially in larger Asian markets.
• Competitive positioning will depend on safety profiles, dosing convenience, and pricing strategies amidst global challengers.
• Regulatory timelines and approval conditions significantly influence financial growth, with rapid approvals in emerging markets being advantageous.
• Cost-effectiveness and real-world evidence play vital roles in securing reimbursement and expanding indications.
• Strategic focus on developing global manufacturing and supply chain capabilities will mitigate risks associated with regional market entry.

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FAQs

1. What makes lusutrombopag distinct from other thrombopoietin receptor agonists?
Lusutrombopag offers a targeted, oral approach with a favorable safety profile specifically approved in Japan for CLD-related thrombocytopenia, distinguishing it from first-generation agents like eltrombopag.

2. In which regions is lusutrombopag currently approved?
It is approved in Japan, with subsequent submissions and expected approvals in China, South Korea, and other parts of Asia. Broader global approval remains pending, contingent upon regulatory review processes.

3. How does pricing influence lusutrombopag’s market penetration?
Pricing, coupled with reimbursement policies, directly impacts adoption rates. Japan’s favorable reimbursement has accelerated uptake, while price sensitivity in emerging markets may slow growth.

4. What are the primary market challenges faced by lusutrombopag?
Challenges include stiff competition, regulatory hurdles in new regions, limited indications outside its approved scope, and pricing pressures from payors.

5. What future opportunities exist for expanding lusutrombopag’s market?
Opportunities include entering new geographic markets, expanding approved indications, and generating robust clinical evidence to enhance prescribing confidence.

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Sources

1. Shionogi & Co. Ltd.. (2018). Approval and Clinical Data for Lusutrombopag.
2. Markets and Markets. Thrombocytopenia Treatment Market Report, 2022.
3. GSK. Eltrombopag Overview and Market Position.
4. Japanese Ministry of Health, Labour and Welfare. Reimbursement Policies for Lusutrombopag.
5. Pharma Intelligence. Sales Data and Market Analysis, 2022.