Letermovir - Generic Drug Details

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

Letermovir is the generic ingredient in one branded drug marketed by MSD and Merck Sharp Dohme, and is included in three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Letermovir has ninety-eight patent family members in forty-eight countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for letermovir

International Patents:	98
US Patents:	2
Tradenames:	1
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	25
Patent Applications:	270
What excipients (inactive ingredients) are in letermovir?	letermovir excipients list
DailyMed Link:	letermovir at DailyMed

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

Constraining patent/regulatory exclusivity:

10,603,384

Dosage:

SOLUTION;INTRAVENOUS

Constraining patent/regulatory exclusivity:

PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])

Dosage:

PELLETS;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 letermovir

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

Sponsor	Phase
University of Pennsylvania	Phase 2
Merck Sharp & Dohme LLC	Phase 2
Maimónides Biomedical Research Institute of Córdoba	Phase 2

See all letermovir clinical trials

Generic filers with tentative approvals for LETERMOVIR

Applicant	Application No.	Strength	Dosage Form
		480MG	TABLET;ORAL
		240MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for letermovir

Drug Class	Cytomegalovirus DNA Terminase Complex Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inhibitors DNA Terminase Complex Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for letermovir

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

US Patents and Regulatory Information for letermovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes	10,603,384		Y
Msd	PREVYMIS	letermovir	PELLETS;ORAL	219104-002	Aug 30, 2024		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017		RX	Yes	No
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017		RX	Yes	No	RE46791		Y	Y

Expired US Patents for letermovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017	7,196,086
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017	7,196,086
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	Nov 8, 2017	7,196,086
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	Nov 8, 2017	8,513,255
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	Nov 8, 2017	7,196,086
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017	8,513,255
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	Nov 8, 2017	8,513,255

EU/EMA Drug Approvals for letermovir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Prevymis	letermovir	EMEA/H/C/004536 Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Consideration should be given to official guidance on the appropriate use of antiviral agents.	Authorised	no	no	yes	2018-01-08

International Patents for letermovir

Country	Patent Number	Title	Estimated Expiration
Argentina	044078	DIHIDROQUINAZOLINAS SUSTITUIDAS
Japan	2006525249
Russian Federation	2360912	ЗАМЕЩЕННЫЕ ДИГИДРОХИНАЗОЛИНЫ С ПРОТИВОВИРУСНЫМИ СВОЙСТВАМИ (SUBSTITUTED DIHYDROQUINAZOLINES HAVING ANTIVIRAL PROPERTIES)
Germany	102012101680	Pharmazeutische Zubereitung enthaltend ein antiviral wirksames Dihydrochinazolinderivat
Hungary	S1800028
China	110433166	含有抗病毒活性二氢喹唑啉衍生物的药物制剂 (Pharmaceutical preparation containing antivirally active dihydroquinazoline derivative)
Canada	2865203	PREPARATION PHARMACEUTIQUE CONTENANT UN DERIVE DE DIHYDROCHINAZOLINE A ACTION ANTIVIRALE (PHARMACEUTICAL COMPOSITION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE)

Supplementary Protection Certificates for letermovir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1622880	C01622880/01	Switzerland		FORMER OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, DE
1622880	C201830035	Spain		PRODUCT NAME: LETERMOVIR, SUS SALES Y SOLVATOS, Y SOLVATOS DE LAS SALES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1245; DATE OF AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1245; DATE OF FIRST AUTHORISATION IN EEA: 20180108
1622880	LUC00080	Luxembourg		PRODUCT NAME: LETERMOVIR, OU UN SEL, SOLVATE OU SOLVATE DE SON SEL; AUTHORISATION NUMBER AND DATE: /EU/1/17/1245 20180110
1622880	132018000000381	Italy		PRODUCT NAME: LETERMOVIR, O IL SUO SALE, SOLVATO O SOLVATO DEL SUO SALE(PREVYMIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1245/001-004, 20180110
1622880	18C1029	France		PRODUCT NAME: LETERMOVIR AINSI QUE SES SELS,SOLVATES ET SELS SOLVATES,PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/17/1245/001-004 20180110
1622880	28/2018	Austria		PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; NAT. REGISTRATION NO/DATE: EU/1/17/1245/001 - EU/1/17/1245/004 (MITTEILUNG) 20180110; FIRST REGISTRATION: EU EU/1/17/1245/001 - EU/1/17/1245/004 20180110
1622880	CR 2018 00026	Denmark		PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE OR SOLVATE OF ITS SALT; REG. NO/DATE: EU/1/17/1245 20180110

Market Dynamics and Financial Trajectory for Letermovir

Introduction

Letermovir, marketed as Prevymis, is an antiviral medication developed by Merck & Co., Inc. for the prevention of cytomegalovirus (CMV) infection in high-risk patients, particularly those undergoing allogeneic hematopoietic stem cell transplantation. Here, we delve into the market dynamics and financial trajectory of letermovir, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Size and Growth Projections

The letermovir market has experienced significant growth in recent years and is expected to continue this trend. According to market research, the letermovir injection market is projected to grow substantially from 2023 to 2031, driven by increasing demand for effective CMV prevention strategies[1].

Segmentation and Target Market

The market for letermovir is segmented based on type (240 mg/12 mL and 480 mg/24 mL formulations), application (hospitals, clinics, and other healthcare settings), and geographical regions (North America, Europe, Asia-Pacific, South America, and the Middle East and Africa). This segmentation helps in understanding the diverse market needs and tailoring strategies accordingly[1].

Clinical Efficacy and Regulatory Approval

Letermovir has demonstrated strong clinical efficacy in preventing CMV infection. A pivotal Phase 3 study showed that letermovir met its primary endpoint in preventing clinically significant CMV infection in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants[3].

Market Drivers

Several factors drive the growth of the letermovir market:

• Increasing Incidence of CMV Infections: The rising number of CMV infections, particularly in immunocompromised patients, fuels the demand for effective prophylactic treatments[4].
• Advancements in Healthcare: Improvements in healthcare infrastructure and the availability of advanced diagnostic tools enhance the detection and treatment of CMV infections, thereby increasing the market for letermovir[4].
• Growing Research and Development: Ongoing research and the development of new therapies for CMV infections contribute to the market's expansion. Letermovir's minimal myelosuppression and tolerability, especially in pediatric patients, are significant advantages[2][4].

Market Restraints

Despite the positive outlook, there are several challenges that could impact the market:

• Side Effects and Immune Impairment: Letermovir has been associated with an increased risk of clinically significant CMV infection and disease requiring antivirals after prophylaxis is discontinued. This can lead to breakthrough CMV viremia and delayed CMV-specific immune reconstitution[2].
• Economic Burden: The cost of antiviral prophylaxis, including letermovir, can be significant, posing a financial burden on patients and healthcare systems[2].

Competitive Landscape

The market for CMV treatments is competitive, with several key players involved:

• Merck & Co., Inc.: As the developer of letermovir, Merck is a major player in this market.
• ModernaTX, Inc.: Moderna is working on innovative mRNA-based therapies for CMV.
• GlaxoSmithKline: GSK is developing vaccine candidates for CMV.
• AlloVir: AlloVir is focused on cell therapies, including posoleucel (ALVR105), for CMV treatment[4].

Financial Trajectory

The financial performance of letermovir is closely tied to its market growth and adoption. Here are some key financial indicators:

• Revenue Growth: The letermovir market is expected to exhibit robust revenue growth over the forecast period, driven by increasing adoption in various healthcare settings[1].
• Pricing and Penetration: The pricing strategy for letermovir, along with its penetration at national and regional levels, will play a crucial role in determining its financial success. Merck's patient assistance programs can also impact revenue by ensuring access to the drug for eligible patients[5].

Geographical Performance

The geographical distribution of the letermovir market is diverse, with significant growth anticipated in various regions:

• North America and Europe: These regions are expected to be major contributors to the market due to advanced healthcare infrastructure and higher awareness of CMV infections.
• Asia-Pacific: This region is also expected to show substantial growth, driven by increasing healthcare spending and the rising incidence of CMV infections[1].

Market Outlook and Trends

The market outlook for letermovir is positive, driven by several trends:

• Increased Public Awareness: Growing awareness about CMV infections and the importance of prophylaxis is driving demand for letermovir.
• Emerging Therapies: The development of novel therapies, including vaccines and cell therapies, is expected to further expand the market for CMV treatments[4].

Challenges and Opportunities

Challenges

• Immune Impairment: The potential for delayed CMV-specific immune reconstitution and breakthrough CMV viremia remains a challenge.
• Economic Burden: The high cost of letermovir and other antiviral therapies can limit access, especially in resource-constrained settings.

Opportunities

• Pediatric Use: Ongoing trials for pediatric use could expand the market significantly if successful.
• Combination Therapies: The potential for combination therapies, such as using letermovir with CMV vaccines, could enhance treatment outcomes and market growth[2].

Key Takeaways

• Robust Growth: The letermovir market is expected to grow significantly from 2023 to 2031.
• Clinical Efficacy: Letermovir has demonstrated strong clinical efficacy in preventing CMV infection.
• Market Drivers: Increasing incidence of CMV infections, advancements in healthcare, and growing research and development drive the market.
• Challenges: Side effects, immune impairment, and economic burden are key challenges.
• Competitive Landscape: Merck, ModernaTX, GlaxoSmithKline, and AlloVir are major players in the CMV treatment market.

FAQs

What is letermovir used for?

Letermovir is used for the prevention of cytomegalovirus (CMV) infection in high-risk patients, particularly those undergoing allogeneic hematopoietic stem cell transplantation.

What are the key drivers of the letermovir market?

The key drivers include the increasing incidence of CMV infections, advancements in healthcare, and growing research and development in CMV treatments.

What are the main challenges associated with letermovir?

The main challenges include the potential for delayed CMV-specific immune reconstitution, breakthrough CMV viremia, and the economic burden of antiviral prophylaxis.

Who are the major players in the CMV treatment market?

Major players include Merck & Co., Inc., ModernaTX, Inc., GlaxoSmithKline, and AlloVir.

What is the expected growth of the letermovir market?

The letermovir market is expected to exhibit robust growth from 2023 to 2031, driven by increasing demand and advancements in healthcare.

Sources

1. Market Research Intellect: Global Letermovir Injection Market Size, Trends and Projections[1].
2. Haematologica: Cytomegalovirus Triplex vaccine in pediatric hematopoietic stem cell transplantation[2].
3. Merck: Merck Announces Pivotal Phase 3 Study of Letermovir, an Investigational Antiviral Medicine for Prevention of Cytomegalovirus (CMV) Infection in High-Risk Bone Marrow Transplant Patients, Met Primary Endpoint[3].
4. GlobeNewswire: Cytomegalovirus Infections Market to Exhibit Moderate Growth by 2032, Evaluates DelveInsight[4].
5. Merck Programs: PREVYMIS (letermovir) 240 mg and 480 mg tablets[5].

Last updated: 2024-12-16