MULPLETA Drug Patent Profile

When do Mulpleta patents expire, and when can generic versions of Mulpleta launch?

Mulpleta is a drug marketed by Vancocin Italia and is included in one NDA. There are three patents protecting this drug.

This drug has forty-one patent family members in twenty countries.

The generic ingredient in MULPLETA is lusutrombopag. One supplier is listed for this compound. Additional details are available on the lusutrombopag profile page.

DrugPatentWatch^® Generic Entry Outlook for Mulpleta

Mulpleta was eligible for patent challenges on July 31, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 29, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MULPLETA

International Patents:	41
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	16
Drug Prices:	Drug price information for MULPLETA
What excipients (inactive ingredients) are in MULPLETA?	MULPLETA excipients list
DailyMed Link:	MULPLETA at DailyMed

See drug prices for MULPLETA

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

Constraining patent/regulatory exclusivity:

9,427,402

NDA:

210923

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.

US Patents and Regulatory Information for MULPLETA

MULPLETA is protected by three US patents.

This potential generic entry date is based on patent 9,427,402.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,427,402		Y
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

Expired US Patents for MULPLETA

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 MULPLETA

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 MULPLETA

When does loss-of-exclusivity occur for MULPLETA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Brazil

Canada

China

European Patent Office

Japan

Russian Federation

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 MULPLETA around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2184279
Japan	2014141518	PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG
Portugal	2184279
South Korea	101849808
South Korea	20100027243	PHARMACEUTICAL COMPOSITION CONTAINING OPTICALLY ACTIVE COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONIST ACTIVITY AND INTERMEDIATE THEREOF
Taiwan	200914000	Pharmaceutical composition containing optically active compounds exhibiting thrombopoietin receptor agonism and their intermediates

Supplementary Protection Certificates for MULPLETA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2184279	122019000065	Germany		PRODUCT NAME: LUSUTROMBOPAG; REGISTRATION NO/DATE: EU/1/18/1348 20190218
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	2019C/534	Belgium		PRODUCT NAME: LUSUTROMBOPAG OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND 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	CA 2019 00038	Denmark		PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220

Market Dynamics and Financial Trajectory for MULPLETA

Introduction

MULPLETA, also known as lusutrombopag, is a thrombopoietin receptor agonist developed by Shionogi & Co., Ltd. for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Launch

MULPLETA was first approved in Japan in 2015 for the improvement of thrombocytopenia associated with chronic liver disease in patients undergoing elective invasive procedures[4]. In the United States, MULPLETA received FDA approval on July 31, 2018, marking it as the second thrombopoietin receptor agonist approved for this indication, following Dova's Doptelet[1].

Market Competition

The launch of MULPLETA in the U.S. market introduced significant competition to Dova's Doptelet. Shionogi priced MULPLETA at $8,500 for a seven-day fixed dose, which is lower than Doptelet's prices of $9,000 for the 40 mg dose and $14,500 for the 60 mg dose. This pricing strategy made MULPLETA about 6% and 70% cheaper than Doptelet, respectively[1].

Clinical Efficacy and Safety

MULPLETA has demonstrated strong clinical efficacy in placebo-controlled phase 3 trials. It significantly increased the proportion of patients who did not require a platelet transfusion prior to procedures or rescue therapy for bleeding. The drug also increased the proportion of patients who achieved a platelet count of ≥ 50 × 10^9/L and an increase of ≥ 20 × 10^9/L from baseline. Headache is the most common adverse reaction reported in clinical trials, indicating that MULPLETA is well tolerated[3].

Market Impact

The launch of MULPLETA had an immediate impact on Dova Pharmaceuticals. Analysts trimmed Dova's target price, and the company's shares dropped roughly 9% in the first hours of trading following the announcement. The competition from MULPLETA was seen as a significant threat to Dova's market share, with analysts noting that promotion, pricing, and access would be key factors in determining long-term market share[1].

Financial Performance

Shionogi's financial performance has been positively influenced by the launch of MULPLETA. The company reported increased revenues and core operating profits in subsequent years. For example, in FY2022, Shionogi recorded revenues of ¥426.7 billion and a core operating profit of ¥158.5 billion, with a core operating profit margin of 37.1%[2].

Revenue Growth

MULPLETA, along with other internally discovered products like Xofluza and cefiderocol, has contributed to Shionogi's revenue growth. The company aims to launch more than 10 new products by fiscal 2030, which is expected to further boost its revenue. Shionogi's overseas revenue ratio, although fluctuating, has shown steady growth, indicating the global market potential of MULPLETA and other products[2].

Cost Management and Efficiency

Shionogi has focused on improving cost management and efficiency. The company has revised agreements for out-licensed products, strengthened cost-control capabilities, and improved the sales ratio of strategic products. These measures have helped in maximizing the value of new products, including MULPLETA[2].

Market Share and Expansion

MULPLETA has captured market share, particularly in patients with more severe thrombocytopenia, due to its competitive pricing and efficacy. Shionogi is working on expanding its business infrastructure in the EU and China, which is expected to increase the global market share of MULPLETA. The drug is also expected to receive approval in Europe in the near future, further expanding its market reach[1][2].

Challenges and Opportunities

Despite the positive market dynamics, Shionogi faces challenges such as the need to improve marketing capabilities and deliver products globally. The company is addressing these issues by strengthening its pipeline, investing in unmet needs, and enhancing its business speed and human resources[2].

Quote from Industry Expert

"As adult patients with CLD often undergo procedures that could put them at increased risk for bleeding, this treatment will offer physicians an option other than platelet transfusions," said Takayuki Yoshioka, CEO of Shionogi, highlighting the medical need and market opportunity for MULPLETA[1].

Future Outlook

Shionogi's integrated report for 2023 outlines ambitious growth targets, including revenue of ¥800.0 billion by fiscal 2030 and an overseas sales CAGR of 15% starting from fiscal 2025. The company's strategy to launch new products, improve cost management, and expand globally is expected to drive the financial trajectory of MULPLETA and other products positively[2].

Statistics

• Revenue: ¥426.7 billion in FY2022[2]
• Core Operating Profit: ¥158.5 billion in FY2022[2]
• Core Operating Profit Margin: 37.1% in FY2022[2]
• Overseas Revenue Ratio: 16.9% in FY2022[2]

Key Takeaways

• MULPLETA is a competitively priced thrombopoietin receptor agonist approved for treating thrombocytopenia in chronic liver disease patients.
• The drug's launch has impacted the market share of Dova's Doptelet due to its lower pricing.
• MULPLETA has demonstrated strong clinical efficacy and safety.
• Shionogi's financial performance has been positively influenced by the drug's launch.
• The company is focusing on global expansion, cost management, and marketing capabilities to further grow the market share of MULPLETA.

FAQs

Q: What is MULPLETA used for?

A: MULPLETA (lusutrombopag) is used for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

Q: How does MULPLETA compare to Doptelet in terms of pricing?

A: MULPLETA is priced at $8,500 for a seven-day fixed dose, which is lower than Doptelet's prices of $9,000 for the 40 mg dose and $14,500 for the 60 mg dose.

Q: What are the common adverse reactions associated with MULPLETA?

A: The most common adverse reaction reported in clinical trials is headache.

Q: How has the launch of MULPLETA affected Dova Pharmaceuticals?

A: The launch of MULPLETA led to a drop in Dova's shares and a reduction in its target price due to the increased competition.

Q: What are Shionogi's future growth targets?

A: Shionogi aims to achieve revenue of ¥800.0 billion by fiscal 2030 and an overseas sales CAGR of 15% starting from fiscal 2025.

Sources

1. BioPharma Dive: Shionogi launches cheaper rival to Dova's Doptelet
2. Shionogi & Co., Ltd.: Integrated Report 2023
3. PubMed: Lusutrombopag: A Review in Thrombocytopenia in Patients with Chronic Liver Disease
4. Shionogi & Co., Ltd.: Shionogi Receives Marketing and Manufacturing Approval in Japan for MULPLETA® Tablets 3mg
5. Shionogi & Co., Ltd.: Future - Shionogi Inc.