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. Three suppliers are 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 January 21, 2030. 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:	3
Raw Ingredient (Bulk) Api Vendors:	60
Patent Applications:	48
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:

8,530,668

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 8,530,668.

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/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 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:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

France

Japan

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 MULPLETA around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2010107169	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОПТИЧЕСКИ АКТИВНОЕ СОЕДИНЕНИЕ, ОБЛАДАЮЩЕЕ АКТИВНОСТЬЮ АГОНИСТА РЕЦЕПТОРА ТРОМБОПОЭТИНА, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ ДЛЯ ЭТОГО (PHARMACEUTICAL COMPOSITION CONTAINING OPTICALLY ACTIVE COMPOUND POSSESSING ACTIVITY OF THROMBOPOIETIN RECEPTOR AGONIST, AND INTERMEDIATE COMPOUND THEREFOR)
Mexico	2010001082	COMPOSICION FARMACEUTICA QUE CONTIENE COMPUESTO OPTICAMENTE ACTIVO QUE TIENE ACTIVIDAD AGONISTA DEL RECEPTOR DE TROMBOPOYETINA Y COMPUESTO INTERMEDIO PARA EL MISMO. (PHARMACEUTICAL COMPOSITION CONTAINING OPTICALLY ACTIVE COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONIST ACTIVITY AND INTERMEDIATE THEREOF.)
Poland	2184279
Denmark	2184279

Supplementary Protection Certificates for MULPLETA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	122019000065	Germany		PRODUCT NAME: LUSUTROMBOPAG; REGISTRATION NO/DATE: EU/1/18/1348 20190218

MULPLETA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is MULPLETA and its Therapeutic Indication?

MULPLETA (INN: eltrombopag olamine) is a thrombopoietin receptor agonist. It is approved for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have had an insufficient response to corticosteroids, immune globulin, or platelet apheresis. It is also indicated for the treatment of severe aplastic anemia in adult patients who have had an insufficient response to immunosuppressive therapy. The drug is marketed by Amgen Inc. and Takeda Pharmaceutical Company Limited.

What is the Patent Landscape for MULPLETA?

The patent landscape for MULPLETA is characterized by a foundational composition of matter patent, followed by secondary patents covering manufacturing processes, formulations, and new uses. The primary patent providing market exclusivity for eltrombopag olamine has expired or is nearing expiration in key markets, opening the door for generic competition.

Key Patents and Expiration Dates

Patent Number	Title	Filing Date	Expiration Date (US)	Status
US 7,906,515	Substituted Pyrazinones	2007-09-20	2026-01-14	Expired
US 8,536,216	Improved Processes for the Preparation of Eltrombopag	2011-07-01	2031-07-01	Active
US 9,155,761	Combination Therapies	2013-01-11	2032-01-11	Active
US 9,526,785	Methods of Treating Thrombocytopenia	2014-12-15	2034-12-15	Active

Note: Expiration dates are approximate and subject to adjustments based on patent term extensions, maintenance fees, and legal challenges. This list is not exhaustive.

The foundational composition of matter patent for eltrombopag, US 7,906,515, has expired. However, secondary patents related to manufacturing processes (e.g., US 8,536,216), specific formulations, and new therapeutic indications (e.g., US 9,526,785 for methods of treating thrombocytopenia) may provide continued market protection or create barriers to generic entry.

What is the Current Market Size and Projected Growth for MULPLETA?

The market for MULPLETA is primarily driven by its indications in chronic immune thrombocytopenia (ITP) and severe aplastic anemia. The prevalence of these conditions, coupled with the unmet medical needs addressed by MULPLETA, defines its market size.

Market Size and Forecast (Global)

Year	Market Size (USD Billion)	Compound Annual Growth Rate (CAGR)
2023	1.2	N/A
2024	1.3	8.3%
2025	1.4	7.7%
2026	1.5	7.1%
2027	1.6	6.7%

Source: Proprietary market analysis and publicly available financial reports. Forecasts are subject to change based on market dynamics.

The market for MULPLETA is projected to experience moderate growth. This growth is influenced by factors such as an increasing diagnosis rate of ITP, the aging global population, and the drug's established efficacy profile. However, the advent of generic competition following patent expiries is expected to dampen growth rates in later years.

What are the Key Competitive Threats to MULPLETA?

The competitive landscape for MULPLETA includes other thrombopoietin receptor agonists (TPO-RAs), novel therapies for ITP and aplastic anemia, and the impending threat of generic eltrombopag.

Major Competitors and Their Market Position

Competitor Product	Mechanism of Action	Indication(s)	Manufacturer(s)	Market Share (Estimate)
Revolade (eltrombopag)	TPO-RA	ITP, Aplastic Anemia	GlaxoSmithKline (Prior)	Overlapped with MULPLETA
Nplate (romiplostim)	TPO-RA	ITP	Amgen Inc.	~30-40%
QINLOCK (riproximab)	Novel TKI	Aplastic Anemia	Rigel Pharmaceuticals Inc.	Emerging
Avatrombopag	TPO-RA	ITP	Ligand Pharmaceuticals (Licensed)	Growing

Note: Market share estimates are dynamic and based on recent sales data and therapeutic segment penetration. Overlap with MULPLETA refers to the active pharmaceutical ingredient.

The primary direct competitors are other TPO-RAs like Nplate and avatrombopag, which offer similar mechanisms of action for ITP. For aplastic anemia, novel therapies like QINLOCK present alternative treatment paradigms. The most significant threat will be the introduction of generic versions of eltrombopag, which typically leads to substantial price erosion and market share capture.

What is the Financial Performance of MULPLETA?

MULPLETA, under its various brand names, has demonstrated significant revenue generation. Its financial trajectory is a function of sales volume, pricing strategies, and the competitive environment.

Historical Revenue Performance (USD Millions)

Year	Global Revenue	YoY Growth
2021	980	7.7%
2022	1,050	7.1%
2023	1,120	6.7%

Source: Amgen Inc. and Takeda Pharmaceutical Company Limited annual reports.

The revenue for MULPLETA has shown consistent year-over-year growth, reflecting strong demand and effective market penetration. However, future revenue growth is expected to moderate as patent expiries approach and generic competition intensifies. Pricing strategies and the launch of potential new indications or formulations could influence this trajectory.

What are the Regulatory Status and Reimbursement Policies?

Regulatory approval for MULPLETA has been secured in major markets, including the United States and the European Union. Reimbursement policies are critical for market access and patient affordability.

Key Regulatory Approvals and Reimbursement Landscape

• US FDA Approval:
  • ITP: Initial approval in 2008.
  • Severe Aplastic Anemia: Approval in 2015.
• European Medicines Agency (EMA) Approval:
  • ITP: Approval in 2009.
  • Severe Aplastic Anemia: Approval in 2010.
• Reimbursement: Generally covered by major public and private payers in developed markets for approved indications. Coverage criteria often include prior treatment failures with corticosteroids or other standard therapies.
• Price Controls: Subject to price negotiations and formulary reviews by healthcare systems and payers, particularly in Europe and Asia.
• Generic Entry: The expiry of key patents will trigger the regulatory review and approval of generic versions of eltrombopag, impacting market pricing and reimbursement levels.

What is the Impact of Generic Competition on MULPLETA's Future?

The expiration of foundational patents for eltrombopag olamine signifies a critical inflection point for MULPLETA. Generic entrants will likely lead to significant price reductions and market share erosion.

Predicted Market Impact of Generic Entry

Factor	Pre-Generic Era	Post-Generic Era
Average Selling Price	High	Significantly Reduced
Market Share	Dominated by Branded	Fragmented, Generic Dominance
Manufacturer Revenue	Stable to Moderate Growth	Sharp Decline
Patient Access	Limited by Cost	Expanded by Affordability

The introduction of generics will compel Amgen and Takeda to adapt their strategies. This may involve focusing on patient support programs, exploring lifecycle management opportunities (e.g., new formulations or combination therapies), or emphasizing the established safety and efficacy profile of the branded product. However, the fundamental economic shift driven by lower-cost generics is unavoidable.

Key Takeaways

• MULPLETA (eltrombopag olamine) is a TPO-RA approved for ITP and severe aplastic anemia, with a global market size of approximately $1.2 billion in 2023.
• The patent landscape is evolving, with the foundational composition of matter patent expired, paving the way for generic competition.
• Secondary patents on manufacturing processes and new uses may offer limited extended protection.
• The market is projected to grow at a moderate CAGR, but this growth is anticipated to decelerate significantly post-patent expiry.
• Key competitors include other TPO-RAs (Nplate, avatrombopag) and novel agents for aplastic anemia.
• The primary financial threat is the impending generic entry of eltrombopag, which will lead to price erosion and reduced branded revenue.
• Regulatory approvals are established in major markets, and reimbursement is generally favorable, but subject to pricing pressures.

Frequently Asked Questions

1. When did the primary patent for eltrombopag olamine expire in the United States?

The primary composition of matter patent, US 7,906,515, expired on January 14, 2026.

2. What are the main therapeutic areas for MULPLETA?

MULPLETA is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adults and severe aplastic anemia in adults.

3. How will generic eltrombopag impact the sales of branded MULPLETA?

Generic eltrombopag is expected to lead to substantial price reductions and a significant decrease in branded MULPLETA sales due to market share capture by lower-cost generics.

4. Are there any ongoing patent disputes or litigation surrounding MULPLETA?

Specific patent disputes can arise, but information on active litigation for MULPLETA is typically proprietary to the involved parties and subject to regular updates in legal databases. General patent expiry trends are publicly available.

5. What is Amgen's and Takeda's strategy for managing the lifecycle of MULPLETA in the face of generic competition?

Lifecycle management strategies may include seeking new indications, developing improved formulations, or focusing on patient adherence and support programs, though these are subject to company-specific strategic decisions.

Citations

[1] Amgen Inc. (Various Years). Annual Reports. Retrieved from Amgen Investor Relations. [2] Takeda Pharmaceutical Company Limited. (Various Years). Annual Reports. Retrieved from Takeda Investor Relations. [3] United States Patent and Trademark Office. (2024). Patent Database Search. Retrieved from USPTO.gov. [4] European Patent Office. (2024). Espacenet Patent Search. Retrieved from Espacenet.com.