MARIBAVIR - Generic Drug Details

What are the generic drug sources for maribavir and what is the scope of freedom to operate?

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

One supplier is listed for this compound.

Summary for MARIBAVIR

US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	15
Patent Applications:	2,807
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
Medical University of South Carolina	Phase 4
Takeda	Phase 4
Takeda	Phase 1

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
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

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/005787 LIVTENCITY 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

Market Dynamics and Financial Trajectory for Maribavir

Introduction

Maribavir, marketed as Livtencity, is a novel oral antiviral drug approved by the US Food and Drug Administration (FDA) in November 2021 for the treatment of refractory or resistant cytomegalovirus (CMV) infection in adult patients who have received a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT). Here, we delve into the market dynamics and financial trajectory of maribavir.

Market Need and Demand

The demand for effective CMV treatments is driven by the increasing incidence of CMV infections, particularly among immunocompromised populations such as organ transplant recipients and individuals with HIV/AIDS. The global CMV treatment market is projected to grow at a CAGR of 6.5% from 2023 to 2032, reaching a value of USD 1,035.16 million by 2032[3].

Clinical Efficacy and Cost-Effectiveness

Maribavir has shown promising results in clinical trials. The SOLSTICE trial demonstrated that maribavir improves CMV viremia clearance and symptom control compared to investigator-assigned therapy (IAT), which includes drugs like ganciclovir, valganciclovir, foscarnet, and cidofovir. However, the efficacy of maribavir is time-limited, and there is uncertainty regarding the maintenance of clearance and recurrence rates[1].

From a cost-effectiveness perspective, maribavir is generally considered more cost-effective than IAT. A study using a two-stage Markov model found that maribavir had lower total costs ($139,751 vs $147,949) and higher quality-adjusted life years (QALYs) (6.04 vs 5.83) compared to IAT. Maribavir's higher acquisition costs were offset by lower costs associated with administration, monitoring, adverse events, and hospitalizations[2].

Pricing and Cost Considerations

The cost of maribavir is a significant factor in its financial trajectory. Each tablet of maribavir costs $276.80, and a typical 7.5-week treatment course costs approximately $58,128. The cost-effectiveness of maribavir is highly sensitive to its price; a price reduction of about 4.5% would be necessary for maribavir to be cost-effective at a $50,000 per QALY threshold[1].

Market Share and Uptake

The market share for maribavir is anticipated to grow, although initial estimates may be overestimated. The sponsor anticipated an uptake of 80% by year three in the new drug market, but this may not reflect real-world clinical practice. The actual market share will depend on various factors, including clinical adoption, reimbursement policies, and competition from other antiviral therapies[1].

Financial Impact on Healthcare Systems

Maribavir's financial impact on healthcare systems is substantial. Despite higher acquisition costs, maribavir reduces overall treatment costs due to lower administration, monitoring, and hospitalization costs. For instance, maribavir-treated patients spent more time without CMV infection, leading to lower retreatment costs and overall cost savings of $42,970.80 compared to IAT[2].

Real-World Experience and Clinical Practice

Real-world experience with maribavir has shown mixed results. In clinical trials and real-world studies, up to 44% of participants did not achieve viral clearance, and up to 35% of initial responders developed recurrent CMV infection. This variability in treatment outcomes highlights the need for careful patient selection and monitoring in clinical practice[4].

Industry Growth Drivers

The growth of the CMV treatment market, including maribavir, is driven by several factors:

• Increasing Incidence of CMV Infections: The rising number of immunocompromised patients increases the demand for effective antiviral treatments.
• Enhanced Awareness and Diagnostics: Improved diagnostic techniques lead to more accurate detection and treatment of CMV infections.
• Advanced Antiviral Therapies: The development of novel antiviral agents like maribavir addresses the growing therapeutic needs.
• Rising Global Healthcare Expenditure: Increased financial allocations to healthcare, especially for infectious diseases, support the market's growth[3].

Conclusion

Maribavir represents a significant advancement in the treatment of refractory or resistant CMV infections, particularly among transplant recipients. Its market dynamics are influenced by its clinical efficacy, cost-effectiveness, and the overall demand for CMV treatments.

Key Takeaways

• Clinical Efficacy: Maribavir improves CMV viremia clearance and symptom control compared to IAT.
• Cost-Effectiveness: Maribavir is generally more cost-effective due to lower administration, monitoring, and hospitalization costs.
• Market Demand: The CMV treatment market is growing, driven by increasing incidence of CMV infections and improved diagnostics.
• Financial Impact: Maribavir reduces overall treatment costs despite higher acquisition costs.
• Real-World Experience: Mixed results in real-world studies highlight the need for careful patient selection and monitoring.

FAQs

Q: What is maribavir used for? A: Maribavir is used for the treatment of refractory or resistant cytomegalovirus (CMV) infection in adult patients who have received a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).

Q: How does maribavir compare to other antiviral therapies in terms of cost-effectiveness? A: Maribavir is generally more cost-effective than investigator-assigned therapy (IAT) due to lower costs associated with administration, monitoring, adverse events, and hospitalizations.

Q: What are the key drivers of the CMV treatment market? A: The key drivers include the increasing incidence of CMV infections, enhanced awareness and diagnostics, advanced antiviral therapies, and rising global healthcare expenditure.

Q: What are the potential limitations of maribavir in real-world clinical practice? A: Maribavir's efficacy can be time-limited, and there is uncertainty regarding the maintenance of clearance and recurrence rates. Up to 44% of participants may not achieve viral clearance, and up to 35% of initial responders may develop recurrent CMV infection.

Q: How does the cost of maribavir impact its financial trajectory? A: The cost of maribavir is a significant factor; a price reduction of about 4.5% would be necessary for maribavir to be cost-effective at a $50,000 per QALY threshold. Despite higher acquisition costs, maribavir reduces overall treatment costs due to lower administration and hospitalization costs.