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LIVTENCITY Drug Patent Profile

Which patents cover Livtencity, and what generic alternatives are available?

Livtencity is a drug marketed by Takeda Pharms Usa and is included in one NDA. There is one patent protecting this drug.

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

DrugPatentWatch^® Generic Entry Outlook for Livtencity

Livtencity will be eligible for patent challenges on November 23, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LIVTENCITY

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	664
Drug Prices:	Drug price information for LIVTENCITY
What excipients (inactive ingredients) are in LIVTENCITY?	LIVTENCITY excipients list
DailyMed Link:	LIVTENCITY at DailyMed

See drug prices for LIVTENCITY

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

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

NDA:

215596

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.

Pharmacology for LIVTENCITY

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

US Patents and Regulatory Information for LIVTENCITY

LIVTENCITY is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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
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

EU/EMA Drug Approvals for LIVTENCITY

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

LIVTENCITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Livtencity

Introduction to Livtencity

Livtencity, also known as maribavir, is a groundbreaking antiviral drug developed by Takeda Pharmaceuticals. It has been approved by the FDA for the treatment of post-transplant cytomegalovirus (CMV) infection in patients who are refractory to one or more of the existing antiviral therapies, including ganciclovir, valganciclovir, foscarnet, or cidofovir[1][4].

Market Need and Demand

The cytomegalovirus treatment market is driven by several key factors, including the increasing incidence of CMV infections 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].

Target Population and Prevalence

Approximately 200,000 adult transplants occur annually worldwide, with about a quarter of these recipients at risk of developing CMV infections. This significant patient pool presents a substantial market opportunity for Livtencity[1].

Clinical Efficacy and Approval

Livtencity has demonstrated superior efficacy in clinical trials. In a phase 3 study, Livtencity more than doubled the proportion of patients who achieved confirmed undetectable blood CMV DNA compared to conventional antiviral therapies. Specifically, 55.7% of patients treated with Livtencity achieved CMV viremia clearance, compared to 23.9% for the control group[1].

The drug's approval was based on a favorable benefit-harm-uncertainty profile, as determined by regulatory bodies such as the FDA and Health Canada. The approval process involved an expedited review, highlighting the drug's potential to treat a serious and life-threatening condition for which no other effective treatments were available[4].

Market Opportunity and Growth Potential

Takeda has projected peak sales for Livtencity to be between $700 million and $800 million, driven by its efficacy and the growing need for effective CMV treatments. The drug's market opportunity extends beyond its current indication, with ongoing studies exploring its potential as a front-line treatment for post-transplant CMV infection. An ongoing phase 3 study is comparing Livtencity to Roche's Valcyte in stem cell transplant patients, with potential approval expected by March 2024[1].

Financial Performance and Projections

Livtencity is part of Takeda's Wave 1 pipeline, which includes several drugs and vaccines expected to drive growth through fiscal year 2024. Takeda's financial performance has been strong, with revenue growth of 11.6% in fiscal year 2021 and continued growth momentum expected in subsequent years. The company's operating profit and net profit have also shown significant increases, reflecting the success of its growth products, including Livtencity[5].

Revenue and Sales Projections

• Peak Sales: Projected to be between $700 million and $800 million[1].
• Market Size: The broader CMV treatment market is expected to grow from USD 627.36 million in 2024 to USD 1,035.16 million by 2032[3].

Impact on Takeda's Financials

• Revenue Growth: Takeda's overall revenue has seen significant growth, with a 13.9% increase in reported revenue in FY2022 Q3. This growth is partly attributed to the performance of new products like Livtencity[2].
• Operating Profit and Net Profit: Despite some fluctuations, Takeda's operating profit and net profit have shown overall positive trends, with net profit increasing by 18.4% in FY2022 Q3[2].

Competitive Landscape

Livtencity enters a market dominated by existing antiviral therapies such as ganciclovir and valganciclovir. However, its novel mechanism of action, targeting CMV at pUL97 to inhibit viral DNA replication, sets it apart. The ongoing phase 3 study comparing Livtencity to Valcyte will further define its competitive position[1].

Challenges and Limitations

Despite its promising market dynamics, the high cost of treatment is a significant challenge that could impede market growth. The cost of advanced antiviral therapies like Livtencity can be prohibitive for some patients, which may affect adoption rates[3].

Future Outlook

The future outlook for Livtencity is promising, given its strong clinical performance and the growing demand for effective CMV treatments. As transplantation activities continue to rise globally, the need for advanced and targeted CMV treatments will escalate, positioning Livtencity for significant market impact.

Ongoing and Future Studies

• Front-line Treatment: Ongoing studies are exploring Livtencity's potential as a front-line treatment for post-transplant CMV infection, which could further expand its market reach[1].

Key Takeaways

• Clinical Efficacy: Livtencity has demonstrated superior efficacy in treating post-transplant CMV infections refractory to existing treatments.
• Market Opportunity: Projected peak sales between $700 million and $800 million, driven by a growing need for effective CMV treatments.
• Financial Performance: Part of Takeda's strong growth pipeline, contributing to the company's overall revenue and profit growth.
• Competitive Advantage: Novel mechanism of action sets it apart from existing antiviral therapies.
• Challenges: High cost of treatment could impede market growth.

FAQs

Q: What is Livtencity used for?

Livtencity (maribavir) is used for the treatment of post-transplant cytomegalovirus (CMV) infection in patients who are refractory to one or more of the existing antiviral therapies.

Q: How effective is Livtencity in treating CMV infections?

In clinical trials, Livtencity more than doubled the proportion of patients who achieved confirmed undetectable blood CMV DNA compared to conventional antiviral therapies, with 55.7% of patients achieving CMV viremia clearance.

Q: What is the projected peak sales for Livtencity?

Takeda has projected peak sales for Livtencity to be between $700 million and $800 million.

Q: What are the key drivers of the CMV treatment market?

The key drivers include the increasing incidence of CMV infections, rising global healthcare expenditure, and the growing emphasis on advanced antiviral therapies.

Q: What are the potential challenges for Livtencity's market growth?

The high cost of treatment is a significant challenge that could impede market growth.

Cited Sources

1. FiercePharma: Takeda's post-transplant CMV drug Livtencity, shouldering $800M in peak sales projections[1].
2. Takeda: Takeda Reinforces Long-term Growth Through Pipeline Advancement and Two Targeted Acquisitions[2].
3. Polaris Market Research: Cytomegalovirus Treatment Market Size, Share, Global Analysis[3].
4. Health Canada: Summary Basis of Decision for Livtencity[4].
5. Takeda: Takeda Delivers Strong FY2021 Results; Continued Growth Momentum Expected in FY2022[5].