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Last Updated: December 30, 2024

Letermovir - Generic Drug Details


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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for letermovir
International Patents:97
US Patents:3
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
Generic Entry Dates for letermovir*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for letermovir*:
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
Generic Entry Dates for letermovir*:
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

SponsorPhase
Merck Sharp & Dohme LLCPhase 2
University of PennsylvaniaPhase 2
Maimónides Biomedical Research Institute of CórdobaPhase 2

See all letermovir clinical trials

Generic filers with tentative approvals for LETERMOVIR
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe480MGTABLET;ORAL
⤷  Subscribe⤷  Subscribe240MGTABLET;ORAL

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

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for letermovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 ⤷  Subscribe ⤷  Subscribe
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 ⤷  Subscribe ⤷  Subscribe
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for letermovir

Country Patent Number Title Estimated Expiration
European Patent Office 4328218 PRÉPARATION PHARMACEUTIQUE COMPRENANT UNE DÉRIVÉ ANTIVIRALE DE DIHYDROQUINAZOLINE (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE) ⤷  Subscribe
New Zealand 628444 Pharmaceutical preparation containing an antivirally active dihydroquinazoline derivative ⤷  Subscribe
South Korea 100927063 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for letermovir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1622880 697 Finland ⤷  Subscribe
1622880 SPC/GB18/027 United Kingdom ⤷  Subscribe PRODUCT NAME: LETERMOVIR, OR ITS SALTS, SOLVATES OR SOLVATES OF THE SALTS; REGISTERED: UK EU/1/17/1245(NI) 20180110; UK PLGB 53095/0046 20180110; UK PLGB 53095/0047 20180110; UK PLGB 53095/0048 20180110; UK PLGB 53095/0049 20180110
1622880 18C1029 France ⤷  Subscribe PRODUCT NAME: LETERMOVIR AINSI QUE SES SELS,SOLVATES ET SELS SOLVATES,PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/17/1245/001-004 20180110
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Letermovir Market Analysis and Financial Projection Experimental

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].

More… ↓

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