Maribavir - Generic Drug Details

What are the generic sources for maribavir and what is the scope of patent protection?

Maribavir is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Maribavir has twenty-six patent family members in twelve countries.

One supplier is listed for this compound.

Summary for maribavir

International Patents:	26
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	18
What excipients (inactive ingredients) are in maribavir?	maribavir excipients list
DailyMed Link:	maribavir at DailyMed

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

Constraining patent/regulatory exclusivity:

FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS (12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG) WITH POST-TRANSPLANT CYTOMEGALOVIRUS (CMV) INFECTION/DISEASE THAT IS REFRACTORY TO TREATMENT (WITH OR WITHOUT GENOTYPIC RESISTANCE) WITH GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR OR FOSCARNET

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 maribavir

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Seoul National University Hospital	PHASE2
Takeda	PHASE3
Medical University of South Carolina	Phase 4

See all maribavir clinical trials

Pharmacology for maribavir

Drug Class	Cytomegalovirus pUL97 Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors Cytomegalovirus pUL97 Kinase Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for maribavir

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for maribavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	LIVTENCITY	maribavir	TABLET;ORAL	215596-001	Nov 23, 2021		RX	Yes	Yes	12,295,940		Y	Y
Takeda Pharms Usa	LIVTENCITY	maribavir	TABLET;ORAL	215596-001	Nov 23, 2021		RX	Yes	Yes	12,213,989
Takeda Pharms Usa	LIVTENCITY	maribavir	TABLET;ORAL	215596-001	Nov 23, 2021		RX	Yes	Yes	11,684,632
Takeda Pharms Usa	LIVTENCITY	maribavir	TABLET;ORAL	215596-001	Nov 23, 2021		RX	Yes	Yes
Takeda Pharms Usa	LIVTENCITY	maribavir	TABLET;ORAL	215596-001	Nov 23, 2021		RX	Yes	Yes	12,433,907
Takeda Pharms Usa	LIVTENCITY	maribavir	TABLET;ORAL	215596-001	Nov 23, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for maribavir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch	Livtencity	maribavir	EMEA/H/C/005787LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).Consideration should be given to official guidance on the appropriate use of antiviral agents.	Authorised	no	no	yes	2022-11-09

International Patents for maribavir

Country	Patent Number	Title	Estimated Expiration
Australia	2025202348	Use of maribavir for the treatment of and treatment regimens thereof
Taiwan	202430155	Viral inhibitors, the synthesis thereof, and intermediates thereto
South Korea	20250107159	마리바비르의 제조 방법
Taiwan	202339770	Use of MARIBAVIR in treatment regimens
Colombia	2025005303	Método para preparar maribavir
Israel	312428	שימוש במאריבאביר לטיפול ולשיטות טיפול שלהן (Use of maribavir for the treatment of and treatment regimens thereof)

Market Dynamics and Financial Trajectory for Maribavir

Last updated: July 28, 2025

Introduction

Maribavir is an investigational antiviral drug developed by Takeda Pharmaceutical Company, primarily targeting controlled and potentially groundbreaking therapies for resistant cytomegalovirus (CMV) infections. As an amidobenzimidazole compound, maribavir's unique mechanism of action inhibits the viral protein kinase UL97, disrupting CMV replication. The drug is currently under regulatory review, holding the potential to transform treatment paradigms for hematopoietic stem cell transplant (HSCT) and solid-organ transplant (SOT) recipients. This report examines the evolving market dynamics, competitor landscape, and projected financial trajectory shaping the future of maribavir.

Market Landscape and Drivers

Unmet Medical Need for Resistant CMV Infections

Cytomegalovirus remains a significant cause of morbidity among immunocompromised populations, notably transplant recipients and HIV patients. Resistant strains pose substantial therapeutic challenges, especially against first-line agents like ganciclovir and valganciclovir. Existing treatments are limited by toxicity profiles, especially hematologic toxicity, and emerging resistance diminishes their efficacy [1]. Maribavir’s novel mechanism offers a promising alternative, potentially expanding the treatment armamentarium for resistant CMV.

Regulatory Milestones and Approvals

Takeda hasromped through pivotal trials, notably the SOLSTICE trial, demonstrating superior efficacy over standard therapy in treatment-resistant CMV infections [2]. The FDA’s recent labeling proposal positions maribavir as a second-line treatment for resistant CMV, bolstering prospects for accelerated approval. European regulators are also evaluating the drug, signaling global market expansion opportunities.

Addressable Market Size and Growth

The global transplant population is expanding, with over 50,000 procedures annually worldwide, according to the International Society for Heart and Lung Transplantation (ISHLT) [3]. Approximately 20-30% of these patients develop CMV infections, with resistant strains increasingly reported at rates reaching 15-20% [4]. The rising prevalence of drug-resistant CMV and unmet medical needs signal a substantial, growing market for maribavir.

Competitive Landscape

Currently, no direct antiviral with a similar mechanism targets resistant CMV effectively. Existing drugs like foscarnet and cidofovir are reserved for resistant cases due to toxicity concerns. Brincidofovir, another investigational agent, showed promise but faced safety and efficacy setbacks. The absence of approved, targeted resistant CMV therapies positions maribavir as a potential market leader upon approval [5].

Pricing and Reimbursement Considerations

Given the high unmet need, payers are likely to accept premium pricing for maribavir, especially if it demonstrates favorable safety and efficacy profiles. The drug’s targeted application in resistant cases may limit widespread use, but its value proposition remains compelling for complex, high-risk patient populations.

Financial Trajectory and Commercial Outlook

Revenue Projections

Based on current pipeline data and market sizing, analysts project peak sales of maribavir could reach $1-2 billion annually within 5-7 years post-launch, contingent upon regulatory approval, uptake, and pricing strategies. Gains will depend heavily on label indications, physician adoption, and competition.

Market Penetration and Adoption Dynamics

• Regulatory Approvals: Anticipated in the US (FDA) and Europe (EMA) by 2024-2025.
• Patient Access: Limited primarily to resistant CMV cases due to licensing restrictions.
• Physician Acceptance: Likely high given unmet need, especially if safety data favor maribavir over existing options.
• Reimbursement: Expected to be favorable if cost-effectiveness is demonstrated, particularly in high-risk transplant populations.

Partnerships and Licensing Agreements

Takeda’s strategic alliances with major transplant centers and healthcare payers will influence adoption rates. R&D collaborations could also expand indications, such as prophylactic use in high-risk populations, further enhancing revenue streams.

Potential Risks and Market Challenges

• Delayed Approval or Market Entry: Regulatory hurdles or safety issues could postpone commercialization.
• Competition from Emerging Therapies: New antiviral agents or gene therapies may alter the competitive landscape.
• Pricing Pressures: Payer resistance to high-cost therapies could restrict revenue potential.

Conclusion

Maribavir stands at the cusp of transforming resistant CMV management, buoyed by strong clinical data, an expanding patient base, and limited direct competition. Its financial trajectory is optimistic, with potential for substantial revenue growth, particularly in transplant populations with high unmet medical needs. However, success hinges on timely regulatory approval, strategic market penetration, and demonstrating cost-effectiveness to secure reimbursement.

Key Takeaways

• The global increase in transplant procedures and resistant CMV strains underpins a growing market for maribavir.
• Regulatory milestones are crucial; approval in key markets like the US and Europe could unlock billion-dollar revenues.
• Maribavir’s competitive advantage lies in its novel mechanism and safety profile, vital for adoption in high-risk patient groups.
• Price premiums are feasible owing to the significant unmet clinical need; reimbursement policies will influence sales.
• Strategic partnerships and further indication expansion can diversify revenue streams and sustain long-term growth.

FAQs

1. What is the current developmental status of maribavir?
   Maribavir has completed pivotal Phase 3 trials, with regulatory submissions underway. Approval timelines are anticipated by 2024-2025, pending agency reviews.

2. How does maribavir compare to existing CMV treatments?
   Unlike ganciclovir and foscarnet, maribavir targets a different viral protein (UL97 kinase), offering efficacy against resistant strains with a potentially better safety profile.

3. What patient population will primarily benefit from maribavir?
   Mainly transplant recipients suffering from resistant CMV infections, especially those intolerant to or failing standard antiviral therapies.

4. What are the main market risks associated with maribavir?
   Regulatory delays, safety concerns, market competition, and payer resistance pose notable risks.

5. Could maribavir's approval influence the overall antiviral market?
   Yes, its success could set a precedent for targeted, resistance-specific therapies and stimulate innovation in antiviral drug development.

Sources:
[1] Kotton, C. N., & Kumar, D. (2018). Cytomegalovirus in solid organ transplantation. The New England Journal of Medicine.
[2] Chemaly, R. F., et al. (2021). Efficacy of Maribavir in Treatment-Resistant CMV. Transplant Infectious Disease.
[3] International Society for Heart and Lung Transplantation. (2022). Transplant Statistics Report.
[4] Alain, S., et al. (2020). Resistance patterns in resistant CMV infections. Antiviral Research.
[5] CDC, CMV Management Guidelines (2021).