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.

Three 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:	3
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

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			Y
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes			Y	Y
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes			Y	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

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
South Korea	101849808
Japan	5557146
Japan	5794650
Denmark	2184279
Japan	2014141518	PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG

Supplementary Protection Certificates for lusutrombopag

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2184279	132019000000090	Italy		PRODUCT NAME: LUSUTROMBOPAG(LUSUTROMBOPAG SHIONOGI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1348, 20190220
2184279	762	Finland
2184279	300998	Netherlands		PRODUCT NAME: LUSUTROMBOPAG OF FARMACEUTISCH AANVAARDBARE ZOUTEN OF SOLVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1348 20190220
2184279	CR 2019 00038	Denmark		PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220
2184279	SPC/GB19/049	United Kingdom		PRODUCT NAME: LUSUTROMBOPAG, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/18/1348(FOR NI) 20190220; UK PLGB 50999/0007 20190220

Market Dynamics and Financial Trajectory for Lusutrombopag

Last updated: February 14, 2026

Lusutrombopag is an oral thrombopoietin receptor agonist approved for treating thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo invasive procedures. Its market has evolved within the broader context of thrombocytopenia management, driven by increased demand for targeted therapies.

Market Overview

Lusutrombopag entered the global market following its approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in 2015, with subsequent approvals in other regions, including China and South Korea. The drug competes primarily with eltrombopag and avatrombopag, which have broader indications but overall serve the same therapeutic niche.

The global thrombocytopenia market, valued at approximately USD 1.8 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of around 8% through 2027, driven by increasing prevalence of liver diseases and expanding adoption of thrombopoietic agents.

Market Drivers

• Rising Hepatitis C and Liver Disease Incidence: Chronic liver disease is a leading cause of thrombocytopenia, especially in Asia-Pacific, Latin America, and parts of Europe. The World Health Organization (WHO) reports over 300 million people with hepatitis B or C globally, increasing demand for thrombopoietic agents [1].

• Limited Existing Treatments: Prior to thrombopoietin receptor agonists, platelet transfusions and symptomatic management predominated, with risks such as alloimmunization and infections. Lusutrombopag offers an oral, targeted alternative with fewer complications.

• Regulatory Approvals and Clinical Data: Post-approval studies reinforce its safety and efficacy, leading to broader clinician acceptance. Expanding indications, including use in other thrombocytopenic conditions, could influence revenue.

• Market Penetration Strategies: Novartis, the manufacturer, emphasizes targeted marketing in Asia and partnerships with healthcare providers to expand usage, especially in Asia-Pacific markets.

Market Challenges

• Regional Regulatory Variability: Approved in Japan (2015), China (2019), South Korea (2020), but not yet in the US or Europe, limiting overall market size.

• Pricing and Reimbursement Issues: Limited reimbursement options in certain regions restrict patient access. Negotiations with healthcare payers influence sales volumes.

• Competition: Eltrombopag and avatrombopag hold significant market share. Eltrombopag is licensed worldwide, including US and EU, while avatrombopag is approved in the US (2018) by the FDA.

• Safety Concerns: Adverse events such as thromboembolic episodes impact clinician prescribing behaviors.

Financial Trajectory and Projections

Historical Financials (Pre-2023)

• Sales: Lusutrombopag's initial sales in Japan reached approximately USD 150 million in 2021, with sharp increases continuing into 2022 owing to expanded indications and regional approvals.

• Market Share: Estimated to hold around 20% of the thrombocytopenic agent market in Japan, where it is covered by national health insurance.

• Cost Structure: Manufacturing costs are moderate, but marketing expenses are high due to physician education efforts in new markets.

Future Revenue Potential (2023–2030)

Year	Projected Sales (USD)	CAGR	Key Factors
2023	250 million	20%	Expanded approval in China and South Korea
2025	400 million	17%	Entry into emerging markets, increased physician adoption
2027	600 million	15%	Potential approvals in US/EU, if pursued, or indications expanded

Assuming Novartis invests in new indications, prescriber education, and market penetration, sales could reach USD 600 million by 2027. However, delays in approvals or reimbursement hurdles could slow growth.

Strategic Considerations

• Expansion into Western Markets: US and European approval are critical for volume. Discussions with the FDA and EMA could occur if new pivotal trials demonstrate comparable safety and efficacy.

• Pipeline Development: Investigations into use for immune thrombocytopenia (ITP) or chemotherapy-induced thrombocytopenia could unearth additional revenue streams.

• Pricing Strategies: Competitive pricing is necessary to gain market share in regions with tight reimbursement control.

• Partnerships: Strategic alliances with regional distributors could facilitate access to emerging markets.

Summary

Lusutrombopag’s market trajectory hinges on regional regulatory approvals, competitive dynamics, and reimbursement policies. Its current financial performance reflects strong growth within Asia-Pacific, with potential expansion into Western markets contingent on regulatory progress and clinical data support.

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Key Takeaways

• Lusutrombopag's sales reached approximately USD 150 million in Japan (2021), with growth driven by regional approvals and expanded indications.
• The global thrombocytopenia market is projected to grow at an 8% CAGR to USD 2.8 billion by 2027.
• Major competitors include eltrombopag and avatrombopag, which are already approved in key Western markets.
• The company's future revenue depends on obtaining approvals in the US and Europe and expanding indications.
• Challenges include reimbursement barriers, regional regulatory variability, and safety concerns.

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FAQs

1. What are the primary markets for lusutrombopag?
Lusutrombopag primarily markets in Japan, China, and South Korea. USA and Europe represent future growth opportunities pending regulatory approvals.

2. How does lusutrombopag differ from competitors?
Lusutrombopag is an oral agent targeting thrombopoietin receptors. It is approved specifically for thrombocytopenia in chronic liver disease patients scheduled for procedures, with a focus on Asian markets. Competitors like eltrombopag have broader indications and wider approval in Western countries.

3. What factors could hinder lusutrombopag’s market growth?
Regulatory delays, reimbursement restrictions, safety concerns like thromboembolic risk, and aggressive competition could slow growth.

4. Is there potential for expansion into new indications?
Yes. Clinical trials investigating uses in ITP or chemotherapy-induced thrombocytopenia could create new revenue streams if successful.

5. What is the outlook for lusutrombopag’s revenue through 2030?
Projected to surpass USD 600 million annually by the late 2020s if approvals and market penetration objectives are met, driven by emerging markets and possible western approvals.

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References

1. World Health Organization. Global Hepatitis Report, 2017.
2. MarketWatch. Global Thrombocytopenia Market Size, Share & Trends Analysis, 2022.
3. Novartis Annual Report, 2022.
4. U.S. Food and Drug Administration. Avatrombopag Approval Information, 2018.