LETERMOVIR - Generic Drug Details

What are the generic drug 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:	62
Clinical Trials:	43
Patent Applications:	955
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
City of Hope Medical Center	PHASE1
National Cancer Institute (NCI)	PHASE1
University Health Network, Toronto	PHASE4

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

Paragraph IV (Patent) Challenges for LETERMOVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREVYMIS	Tablets	letermovir	240 mg and 480 mg	209939	1	2024-10-16

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	209940-002	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes
Msd	PREVYMIS	letermovir	PELLETS;ORAL	219104-002	Aug 30, 2024		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	Nov 8, 2017		RX	Yes	Yes	RE46791		Y	Y
Msd	PREVYMIS	letermovir	PELLETS;ORAL	219104-001	Aug 30, 2024		RX	Yes	No	RE46791		Y	Y
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	8,513,255
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	Nov 8, 2017	8,513,255
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	7,196,086

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/004536Prevymis 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
Philippines	12014501937	PHARMACEUTICAL COMPOSITION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
European Patent Office	4328218	PRÉPARATION PHARMACEUTIQUE COMPRENANT UNE DÉRIVÉ ANTIVIRALE DE DIHYDROQUINAZOLINE (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE)
Norway	333265
Tunisia	2014000345	PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
Malaysia	144616	SUBSTITUTED DIHYDROQUINAZOLINES
Peru	20050145	DIHIDROQUINAZOLINAS SUSTITUIDAS COMO AGENTES ANTIVIRALES
Poland	3556350

Supplementary Protection Certificates for LETERMOVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1622880	327 50010-2018	Slovakia		OWNER(S): AIC246 GMBH&CO. KG, WUPPERTAL, DE; PREVIOUS OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, WUPPERTAL, DE;
1622880	1890019-1	Sweden		PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE OR SOLVATE OF ITS SALT; REG. NO/DATE: EU/1/17/1245 20180110
1622880	300933	Netherlands		PRODUCT NAME: LETERMOVIR; REGISTRATION NO/DATE: EU/1/17/1245 20180110
1622880	C 2018 027	Romania		PRODUCT NAME: LETERMOVIR SAU SAREA SA, SOLVATUL SAU, SAU SOLVATUL SARII SALE; NATIONAL AUTHORISATIONNUMBER: EU/1/17/1245; DATE OF NATIONAL AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EU ROPEAN ECONOMIC AREA (EEA): EU/1/17/1245; DATE OF FIRST AUTHORISATION IN EEA: 20180108
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	CR 2018 00026	Denmark		PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE OR SOLVATE OF ITS SALT; REG. NO/DATE: EU/1/17/1245 20180110
1622880	122018000080	Germany		PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; REGISTRATION NO/DATE: EU/1/17/1245 20180108

LETERMOVIR: Market Dynamics and Financial Trajectory

Last updated: March 4, 2026

What is Letermovir and its approved indications?

Letermovir is a viral DNA terminase complex inhibitor approved for the prevention of cytomegalovirus (CMV) infection and disease in adult recipients of an allogeneic hematopoietic stem cell transplant (allo-HSCT). It was developed by Merck & Co. and received FDA approval in November 2017.

How is the competitive landscape structured?

The primary competitor for CMV prophylaxis is ganciclovir. However, ganciclovir's toxicity profile, notably myelosuppression, limited its use. CDC recommends valganciclovir, a prodrug of ganciclovir, as first-line therapy. Other drugs include foscarnet and cidofovir, reserved for resistant cases. Letermovir's approval created a new market segment focused on prophylaxis with fewer side effects.

What are the current market penetration figures?

As of 2022, letermovir sales reached approximately $370 million globally (IQVIA, 2022). North America accounts for over 85% of revenue, driven by high transplant volumes and established treatment protocols. Europe's market share is growing, with sales around $40 million, reflecting adoption rates in major countries like Germany and the UK. The rest of the world contributes less than 5%, limited by regulatory access.

What are the key factors influencing its market trajectory?

• Transplant Volume: The primary determinant. US allo-HSCT procedures increased 2–3% annually pre-pandemic, with a slight dip in 2020 and recovery thereafter (ASBMT, 2021). Market expansion hinges on transplant growth.

• Pricing and Reimbursement: In the US, Letermovir's wholesale acquisition cost (WAC) is approximately $250 per 480 mg dose. Payer coverage varies but generally favors prophylactic medication costs over managing CMV disease complications.

• Market Adoption and Guidelines: Adoption by hematologists depends on institutional guidelines, safety profile, and physician familiarity. The European Society for Blood and Marrow Transplantation incorporates Letermovir into prophylaxis algorithms.

• Patent and Exclusivity: Patent protection extends until at least 2027. No significant generic competition exists currently, supporting sustained revenue.

• Further Indications: Ongoing trials targeting CMV in solid organ transplant recipients could broaden use cases. Positive results could drive revenue growth.

How do regulatory and pipeline developments impact the outlook?

• Regulatory Approvals: Expanding approvals to other indications, such as solid organ transplantation, could expand the market size.

• Pipeline Drugs: Competing agents in development target CMV or other herpesviruses. Resistance development could limit lead drugs' longevity. Currently, no direct generics threaten Letermovir’s exclusivity.

• Pricing Pressure: Increased scrutiny over drug prices, especially from public payers, could influence revenue margins.

Financial outlook and growth projections

Based on current trends, estimates suggest:

Year	Global Sales (millions USD)	Growth Rate	Remarks
2022	370	-	First-year revenue data in market reports
2023	410	10.8%	Slight increase due to expanding transplant volume
2024	455	11.0%	Expected uptake in Europe, pipeline approval influence
2025	500	9.9%	Stabilization, possible patent expiration impact
2030	>800	Based on transplant growth, pipeline, and wider adoption	Long-term growth potential

Risks and opportunities

Risks

• Patent expiration approaching 2027 could allow generics.
• Resistance might develop, diminishing efficacy.
• Market saturation in North America could slow growth.

Opportunities

• Global expansion, especially in Asia-Pacific.
• Approval for new indications, including solid organ transplants.
• Potential combination therapies increasing prophylactic efficacy.

Summary

Letermovir's market is primarily driven by allo-HSCT procedures, with existing high uptake in North America. The drug's growth trajectory depends on transplant volumes, reimbursement policies, and regulatory approvals. Patent life till 2027 offers a window of exclusivity, with future competition contingent on pipeline developments and generics. Long-term growth prospects remain favorable if expansion into new indications and geographies materialize.

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Key Takeaways

• Letermovir generated approximately $370 million worldwide in 2022, predominantly in North America.
• Market growth relies on hematopoietic stem cell transplant rates, which are gradually recovering post-pandemic.
• Patent protection lasts until at least 2027, with no current generic competition.
• Expansion into solid organ transplant and emerging global markets offers growth opportunities.
• Resistance development and market saturation are primary risks.

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FAQs

1. Will generic versions of Letermovir enter the market after patent expiration?
Yes. Patent expiry around 2027 could lead to generic competition, potentially reducing prices and market share.

2. Are there ongoing studies for additional indications of Letermovir?
Yes. Trials are ongoing for using Letermovir in solid organ transplants and other CMV-related conditions, which could expand its markets.

3. How does Letermovir compare cost-wise to existing CMV prophylactics?
Its per-dose cost is higher than older therapies like ganciclovir, but offset by a more favorable safety profile and reduced hospitalization due to fewer side effects.

4. What factors could accelerate adoption outside North America?
Regulatory approvals, inclusion in local treatment guidelines, and reimbursement alignments are crucial drivers.

5. How vulnerable is Letermovir to resistance development?
While resistance reports are limited, CMV resistance mutations can develop with prolonged exposure. Monitoring and combination strategies may mitigate this risk.

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References

[1] IQVIA. (2022). Market sales data for Letermovir.
[2] American Society for Blood and Marrow Transplantation (ASBMT). (2021). Transplant procedure statistics.
[3] European Society for Blood and Marrow Transplantation. (2022). Treatment guidelines and market reports.