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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lusutrombopag has fifty-six patent family members in twenty countries.

One supplier is listed for this compound.

Summary for lusutrombopag

International Patents:	56
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	3
Patent Applications:	45
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
Shionogi	Phase 3
Shionogi	Phase 2

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	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
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes			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/004720 Mulpleo 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
Japan	4106066
Japan	5557146
Spain	2949552
Japan	2008110998	COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONISM
World Intellectual Property Organization (WIPO)	2005014561
Spain	2599529

Supplementary Protection Certificates for lusutrombopag

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2184279	CA 2019 00038	Denmark		PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. 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
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	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	2019C/534	Belgium		PRODUCT NAME: LUSUTROMBOPAG OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1348 20190220

Lusutrombopag Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lusutrombopag

Introduction to Lusutrombopag

Lusutrombopag, developed by Shionogi & Co., Ltd., is a small molecule drug that targets the thrombopoietin (TPO) receptor to treat thrombocytopenia, a condition characterized by a low platelet count. This drug has gained significant attention for its efficacy in treating patients with chronic liver disease (CLD) and other conditions associated with thrombocytopenia.

Market Size and Growth

The oral thrombopoietin receptor agonists market, which includes lusutrombopag, is experiencing robust growth. As of 2023, the global market size was estimated at $4.73 billion and is projected to reach $9.95 billion by 2034, growing at a compound annual growth rate (CAGR) of 7% from 2024 to 2034[1].

Segment Performance

By Type

The lusutrombopag segment is expected to witness notable growth within the oral thrombopoietin receptor agonists market. While eltrombopag currently holds a significant share due to its use in treating chronic immune thrombocytopenia (ITP), lusutrombopag is gaining traction for its effectiveness in treating thrombocytopenia associated with CLD. This drug is particularly valuable for patients undergoing invasive procedures, as it safely increases platelet counts and reduces the need for platelet transfusions[1].

By Application

The hospital and clinic segment dominates the market for oral thrombopoietin receptor agonists, including lusutrombopag. This is because these medications are primarily used to treat conditions such as ITP and CLD, which require professional supervision and care in hospital settings[1].

Regulatory Approvals and Clinical Trials

Lusutrombopag received its first approval in Japan in September 2015 and has since been approved in other countries globally. The drug has completed the highest phase of clinical trials and has been granted fast track status, indicating its potential to address an unmet medical need. This fast track designation underscores the drug's efficacy and safety profile[4].

Financial Performance of Shionogi & Co., Ltd.

Revenue and Sales

Shionogi & Co., Ltd. has seen significant revenue growth driven by the success of its new products, including lusutrombopag. In the financial year 2017, the company reported strong sales growth of strategic products, including an increase in royalty income from the HIV franchise and payments from Roche related to other projects. The sales of new products, such as lusutrombopag, contributed substantially to the company's revenue, with a notable increase in sales during this period[5].

Research and Development (R&D) Investments

Shionogi has been investing heavily in R&D, particularly in the global development of its strategic products. The company's R&D expenses have increased, reflecting its commitment to advancing clinical trials and obtaining regulatory approvals. For instance, the rolling submission of the New Drug Application (NDA) for lusutrombopag in the US was a key milestone, indicating the company's focus on expanding the drug's market reach[5].

Operating Income and Profit

The financial performance of Shionogi & Co., Ltd. has been influenced by the success of lusutrombopag and other new products. The company's operating income and profit have seen fluctuations, but overall, the growth in sales of strategic products has contributed positively to the company's financial trajectory. Despite some decreases in certain segments, the overall trend indicates a strong financial position driven by innovative products like lusutrombopag[3].

Regional Market Dynamics

The Asia Pacific region, particularly Japan, has been a significant market for lusutrombopag. The region's large population and growing investment in healthcare have boosted the demand for oral thrombopoietin receptor agonists. Shionogi & Co., Ltd.'s strong presence in Japan and its collaborations with other stakeholders have further enhanced the market growth in this region[1].

Competitive Landscape

The market for oral thrombopoietin receptor agonists is competitive, with several players involved in research and development. However, lusutrombopag's unique mechanism of action and its approval in multiple countries have positioned it as a valuable treatment option. Shionogi & Co., Ltd.'s strategic investments in R&D and its focus on global expansion have helped the company maintain a competitive edge in this market[4].

Future Outlook

Given the growing demand for effective treatments for thrombocytopenia and the expanding approvals for lusutrombopag, the financial trajectory for this drug is promising. The projected growth in the oral thrombopoietin receptor agonists market, coupled with Shionogi's continued investment in R&D, suggests that lusutrombopag will remain a significant contributor to the company's revenue and profitability in the coming years.

Key Takeaways

• Market Growth: The oral thrombopoietin receptor agonists market, including lusutrombopag, is expected to grow at a CAGR of 7% from 2024 to 2034.
• Segment Performance: Lusutrombopag is expected to witness notable growth, particularly in treating thrombocytopenia associated with CLD.
• Regulatory Approvals: Lusutrombopag has received approvals in multiple countries and has been granted fast track status.
• Financial Performance: Shionogi & Co., Ltd.'s revenue and profit have been positively impacted by the success of lusutrombopag.
• Regional Dynamics: The Asia Pacific region, especially Japan, is a significant market for lusutrombopag.
• Competitive Landscape: Lusutrombopag's unique mechanism and global approvals have positioned it as a valuable treatment option.

FAQs

1. What is lusutrombopag used for? Lusutrombopag is used to treat thrombocytopenia, a condition characterized by a low platelet count, particularly in patients with chronic liver disease (CLD).

2. Who developed lusutrombopag? Lusutrombopag was developed by Shionogi & Co., Ltd., a pharmaceutical company based in Japan.

3. What is the current market size for oral thrombopoietin receptor agonists? As of 2023, the global market size for oral thrombopoietin receptor agonists was estimated at $4.73 billion.

4. What is the projected growth rate for the oral thrombopoietin receptor agonists market? The market is projected to grow at a CAGR of 7% from 2024 to 2034.

5. Where was lusutrombopag first approved? Lusutrombopag received its first approval in Japan in September 2015.

Sources

1. Towards Healthcare: Oral Thrombopoietin Receptor Agonists Market Size, Shares and Trends.
2. Shionogi Inc.: FY 2016 Financial Results.
3. Shionogi Inc.: FY 2019 Financial Results.
4. Synapse by PatSnap: Exploring lusutrombopag's Revolutionary R&D Successes.
5. Shionogi Inc.: 1st Half of Fiscal 2017 Financial Results.