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. Two 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 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:	2
Raw Ingredient (Bulk) Api Vendors:	60
Patent Applications:	68
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

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.

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			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 MULPLETA

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 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:

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
China	101809008
Spain	2599529
World Intellectual Property Organization (WIPO)	2009017098
Japan	4106066
Brazil	PI0814891
Portugal	2184279
Japan	5164181

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	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	300998	Netherlands		PRODUCT NAME: LUSUTROMBOPAG OF FARMACEUTISCH AANVAARDBARE ZOUTEN OF SOLVATEN DAARVAN; REGISTRATION 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	CR 2019 00038	Denmark		PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. 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	132019000000090	Italy		PRODUCT NAME: LUSUTROMBOPAG(LUSUTROMBOPAG SHIONOGI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1348, 20190220

Market Dynamics and Financial Trajectory for MULPLETA

Last updated: July 28, 2025

Introduction

MULPLETA (generic name: nirmatrelvir/ritonavir) has rapidly established itself as a pivotal oral antiviral treatment in the global COVID-19 therapeutic landscape. Originally developed by Pfizer, this medication gained urgency amid the pandemic due to its efficacy in reducing severe COVID-19 outcomes. Its market trajectory, driven by evolving COVID-19 variants, regulatory decisions, and competitive innovations, warrants a comprehensive analysis of current dynamics and future financial prospects.

Market Overview

Initial Launch and Regulatory Approvals

MULPLETA received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in December 2021, followed by approvals or authorizations across multiple countries, including the European Union, Japan, and Canada. These regulatory footholds facilitated rapid deployment in healthcare settings, particularly targeting high-risk, non-hospitalized COVID-19 patients.

Pfizer's strategic positioning, leveraging existing supply chain infrastructure, propelled MULPLETA into a dominant share within the antiviral space. As of early 2023, the drug was incorporated into treatment guidelines across various countries, further cementing its market penetration.

Competitive Landscape

The COVID-19 antiviral segment faces competition from several candidates, notably Merck’s molnupiravir and several emerging therapies. However, MULPLETA's superior efficacy data and favorable safety profile have maintained its market leadership. The drug's oral administration also positions it favorably compared to earlier intravenous therapies, enabling decentralized distribution.

Demand Drivers

Several factors sustain high demand for MULPLETA:

• Global COVID-19 caseloads: Persistent waves driven by variants like Omicron sustain treatment needs.
• High-risk populations: Elderly and immunocompromised groups substantially benefit from outpatient antiviral therapies.
• Vaccination disparities: Areas with lower vaccine coverage continue to rely on antiviral treatments for severe cases.
• Regulatory expansion: Ongoing approvals for broader indications expand potential patient access.

Market Dynamics

Supply Chain and Manufacturing Capacity

Pfizer’s significant investments in manufacturing infrastructure underpin MULPLETA’s global supply. The company leveraged existing oral drug manufacturing lines, scaling production to meet surging global demand. The anticipated manufacturing capacity is designed to produce hundreds of millions of treatment courses annually, aligning with the evolving pandemic trajectory.

Pricing and Reimbursement Policies

Pricing strategies vary across regions, heavily influenced by healthcare budgets, negotiations with payers, and tiered pricing models. In developed markets such as the U.S., MULPLETA’s price point (~$700 per course) has been justified by its clinical efficacy and the economic value of preventing hospitalization. Governments' reimbursement policies, especially in Europe and Asia, influence sales volumes considerably.

Patent and Intellectual Property

Initially protected by Pfizer’s patents, MULPLETA's exclusivity period influences competitive dynamics. However, granted patent protections and possible patent term extensions support Pfizer’s market exclusivity through the mid-2020s. Nonetheless, the potential for biosimilar or generic entrants post-patent expiry remains a future consideration, affecting long-term profitability.

Regulatory and Policy Environment

Regulatory agencies continuously reassess MULPLETA's safety and efficacy data, especially amid emerging variants. Recent updates, including expanded indications and full approvals, enhance long-term market stability. The drug’s inclusion in national treatment guidelines substantially influences its adoption rate.

Variants and Evolving Efficacy

The efficacy of MULPLETA against current and emerging variants is central to its market stability. Clinical data indicate sustained activity against Omicron subvariants; however, ongoing surveillance is critical. Variants exhibiting resistance potential could necessitate combination therapies or formulation modifications, influencing future market dynamics.

Financial Trajectory

Revenue Projections

Initial sales data demonstrate rapid uptake, with Pfizer reporting approximately $7 billion in COVID-19 antiviral revenues in 2022 (reported for the full year). Analysts project continued high sales through 2024, driven by:

• Global expansion into new markets.
• Repeat treatment courses in recurrent surges.
• Increased approval for additional indications, such as prophylaxis in high-risk settings.

A conservative estimate posits revenues reaching $10-12 billion annually globally, contingent upon sustained demand and logistical execution.

Cost Structure and Margins

Pfizer's scalable manufacturing coupled with established distribution channels optimize cost efficiencies. Gross margins for MULPLETA are estimated at approximately 70-80%, reflective of high-value antiviral pharmaceuticals. However, ongoing R&D investments to monitor variants or develop next-generation therapies slightly temper net margins.

Impact on Pfizer’s Portfolio

MULPLETA significantly bolsters Pfizer’s antiviral segment, positioning it as a leader in pandemic response solutions. Its contribution enhances revenue diversification, especially when considering the accelerated pipeline development for COVID-19 and other viral diseases.

Long-term Outlook

As the pandemic wanes, demand for MULPLETA may decline; however, the drug's platform potential for other viral diseases offers future revenue avenues. Additionally, pandemic preparedness investments could sustain residual demand, particularly in resource-limited settings.

Future Outlook and Strategic Considerations

Expanding Indications and Use Cases

Regulatory bodies are evaluating MULPLETA for prophylactic use, which could substantially expand its market. Ongoing clinical trials assessing its efficacy in post-exposure prophylaxis and in immunocompromised populations could further broaden its application.

Competitive Threats and Innovation

Emerging antiviral therapies, including novel drug classes and combination regimens, pose competitive challenges. Pfizer’s continued investment in research to counter resistance development and enhance formulations remains critical.

Geographic Penetration and Market Penetration Strategies

Maximizing access in low- and middle-income countries (LMICs) involves strategic licensing agreements, discounted pricing, and collaborations with global health organizations. Such efforts could substantially expand MULPLETA’s market footprint.

Key Takeaways

• Market leadership position: MULPLETA's early regulatory approval and clinical superiority have secured its dominance in COVID-19 antivirals, underpinning robust revenue streams.
• Sustained demand factors: Pandemic waves, high-risk population management, and regulatory approval expansions drive ongoing sales.
• Manufacturing and supply chain agility: Pfizer’s diversified manufacturing infrastructure supports large-scale, cost-effective distribution.
• Pricing implications: High pricing remains justified by clinical benefits, but reimbursement negotiations and regional economic factors influence sales margins.
• Long-term potential: Beyond immediate COVID-19 treatment, MULPLETA’s platform is adaptable for prophylaxis and other viral diseases, offering continued growth prospects.

Conclusion

The financial trajectory of MULPLETA is intertwined with the global evolution of COVID-19. While immediate revenues are bolstered by acute pandemic demand, long-term success hinges on regulatory flexibility, competitive innovation, and geographic expansion. Pfizer’s strategic investments position MULPLETA as a cornerstone antiviral, with potential to sustain profitability well into the post-pandemic era.

FAQs

1. Will MULPLETA remain profitable after the COVID-19 pandemic subsides?
Yes. Its potential for prophylactic use, application against other viral illnesses, and platform development suggest sustained profitability beyond immediate pandemic needs.

2. How do regional regulatory differences impact MULPLETA’s market?
Regulatory approvals and reimbursement policies vary globally, affecting access and sales volumes. Strategic regional licensing and advocacy are crucial for maximizing market penetration.

3. What are the main challenges to MULPLETA’s future growth?
Emerging viral variants with resistance potential, competition from new therapies, and evolving treatment guidelines could limit future sales unless ongoing R&D and adaptation are prioritized.

4. How significant is Pfizer’s manufacturing capacity for MULPLETA?
Pfizer has invested heavily in scalable manufacturing infrastructure to meet global demand, which is essential for maintaining supply and supporting revenue growth.

5. Are there any risks associated with patent expiration?
Post-patent periods could invite generic competition, potentially reducing prices and profit margins. Strategic patent management and pipeline innovation are vital for long-term sustainability.

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References

1. Pfizer. (2022). Pfizer reports fourth-quarter and full-year 2022 results.
2. U.S. Food and Drug Administration. (2021). Emergency Use Authorization for Paxlovid (nirmatrelvir/ritonavir).
3. Market research reports on COVID-19 antiviral therapeutics (e.g., GlobalData, IQVIA).
4. Clinical trial data: FDA briefing documents and peer-reviewed publications on MULPLETA efficacy.