PREVYMIS Drug Patent Profile

Which patents cover Prevymis, and when can generic versions of Prevymis launch?

Prevymis is a drug marketed by MSD and Merck Sharp Dohme and is included in three NDAs. There are two patents protecting this drug.

This drug has ninety-eight patent family members in forty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Prevymis

Prevymis was eligible for patent challenges on November 8, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 30, 2031. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (letermovir), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for PREVYMIS

International Patents:	98
US Patents:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	9
Drug Prices:	Drug price information for PREVYMIS
What excipients (inactive ingredients) are in PREVYMIS?	PREVYMIS excipients list
DailyMed Link:	PREVYMIS at DailyMed

See drug prices for PREVYMIS

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

NDA:

209940

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-])

NDA:

209939

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-])

NDA:

219104

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 PREVYMIS

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

Sponsor	Phase
Merck Sharp & Dohme LLC	PHASE1
Jason A Roberts	PHASE1
Royal Brisbane and Women's Hospital	PHASE1

See all PREVYMIS clinical trials

Pharmacology for PREVYMIS

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

US Patents and Regulatory Information for PREVYMIS

PREVYMIS is protected by two US patents and eight FDA Regulatory Exclusivities.

This potential generic entry date is based on 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-]).

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

Expired US Patents for PREVYMIS

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

EU/EMA Drug Approvals for PREVYMIS

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 PREVYMIS

When does loss-of-exclusivity occur for PREVYMIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Germany

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREVYMIS around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2819648	PRÉPARATION PHARMACEUTIQUE COMPRENANT UNE DÉRIVÉ ANTIVIRALE DE DIHYDROQUINAZOLINE (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE)
South Korea	100927063
Israel	234363	תכשיר רוקחות המכיל נגזרת דיהידרוקוינאזולין עם פעילות אנטי-נגיפית (Pharmaceutical preparation containing an antivirally active dihydroquinazoline derivative)
Ukraine	111415	ФАРМАЦЕВТИЧНИЙ ПРЕПАРАТ, ЩО МІСТИТЬ ПОХІДНУ ДИГІДРОХІНАЗОЛІНУ З ПРОТИВІРУСНОЮ АКТИВНІСТЮ (PHARMACEUTICAL PREPARATION CONTAINING DIHYDROQUINAZOLINE DERIVATIVE POSSESSING ANTIVIRAL ACTIVITY)
Slovenia	1622880
San Marino	T201900458

Supplementary Protection Certificates for PREVYMIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1622880	300933	Netherlands		PRODUCT NAME: LETERMOVIR; REGISTRATION NO/DATE: EU/1/17/1245 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	CA 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
1622880	C01622880/01	Switzerland		FORMER OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, DE
1622880	697	Finland

Market Dynamics and Financial Trajectory for PREVYMIS (Letermovir)

Last updated: December 27, 2025

Executive Summary

PREVYMIS (letermovir) represents a pivotal innovation in antiviral therapeutics, primarily targeting the prevention of cytomegalovirus (CMV) infections in hematopoietic stem cell transplant (HSCT) recipients. Since its FDA approval in 2017, PREVYMIS's market trajectory has been shaped by evolving clinical indications, competitive landscape shifts, and regulatory developments. This analysis details the current market environment, projected financial trajectory, key competitors, regulatory influences, and strategic opportunities, providing a comprehensive outlook for stakeholders.

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What Are the Market Drivers for PREVYMIS?

1. Increasing Incidence of CMV in Transplant Patients

The global HSCT market was valued at approximately $7.83 billion in 2022, with infection management constituting a significant subset. CMV infection remains a leading cause of morbidity and mortality post-transplant, affecting up to 70-80% of seropositive donors and recipients. The rising number of transplants globally, projected at a CAGR of 5.8% (2023–2030), increases the demand for effective prophylactic agents like PREVYMIS.

2. Expanding Indications and Broader Patient Demographics

Originally approved for prophylaxis in adult CMV-seropositive HSCT recipients, PREVYMIS's label extension in 2020 expanded its use to include adult CMV prophylaxis in solid organ transplant (SOT) patients. This diversification broadens its addressable market, especially as organ transplant procedures witness steady growth (~7% CAGR).

3. Favorable Efficacy and Safety Profile

Compared to traditional agents like ganciclovir or valganciclovir, PREVYMIS offers a unique mechanism—targeting the terminase complex of CMV—which results in fewer hematological adverse effects. This safety advantage facilitates wider adoption, especially in high-risk populations prone to drug-induced cytopenias.

4. Competitive Strategies & Pricing Policies

Initiatives such as payer negotiations, coverage policies by CMS, and inclusion in clinical guidelines (e.g., ASCO, AST) influence market penetration. Currently, the average wholesale price (AWP) for PREVYMIS is approximately $643 per 480 mg vial, but reimbursement dynamics significantly impact net revenues.

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What Is the Current Market Size and Revenue Forecast?

Metric	Figures & Projections
2022 Global Market (CMV prophylaxis)	~$240 million (estimated)
2017 (Launch) Revenue	~$60 million
2023 Forecast	~$300 million (expected)
CAGR (2023–2028)	~12%
Market Penetration (by 2028)	Approximately 55-60% of eligible transplant patients

Revenue Drivers

• Geographic Expansion: Increasing uptake in Europe and Asia-Pacific.
• New Indications: Exploration for use in other viral infections and preventive indications.
• Pricing & Reimbursement: Payor shifts toward favoring prophylaxis for at-risk patients.

Revenue Breakdown by Region (2023 Estimate)

Region	% of Revenue	Growth Rate (YoY)	Key Factors
North America	55%	10%	Established market, high transplant volume
Europe	25%	12%	Expanded approval, HEOR efforts
Asia-Pacific	15%	15%	Growing transplant programs, price sensitivity
Rest of World	5%	8%	Emerging markets, regulatory timelines

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Who Are the Key Competitors and How Do They Impact PREVYMIS's Market?

Competitor	Mechanism of Action	Market Position	Strengths	Limitations
Ganciclovir / Valganciclovir	Nucleoside analogs, inhibit DNA synthesis	Dominant but prescritionally limited due to toxicity	Well-established, extensive clinical data	Hematological toxicity, resistance concerns
Letermovir (PREVYMIS)	Terminase complex inhibitor	Growing rapidly	Better safety profile, specific prophylaxis	Higher cost, limited indication scope
Maribavir	UL97 kinase inhibitor	Approved for resistance/emergency use	Novel mechanism, effective in resistant cases	Cost, clinician familiarity
Brincidofovir	Lipid conjugate, inhibits viral DNA polymerase	Early-stage, experimental	Broad antiviral activity	Safety concerns, limited data

Market Share (2023):	Agent	Estimated Market Share	Notes
Ganciclovir	45%	Despite toxicity issues, remains first-line
PREVYMIS	30%	Rapid growth due to safety and efficacy
Others	25%	Includes newer agents and off-label uses

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How Are Regulatory Policies Shaping PREVYMIS's Path?

FDA & EMA Approvals

• FDA (2017): Approved for CMV prophylaxis in adult HSCT recipients.
• EMA (2018): Approved for similar indications in Europe.
• Label Extensions: 2020 expanded to include adult SOT patients.

Guideline Inclusion

• ASBMT (American Society for Blood and Marrow Transplantation): Recommends prophylaxis for high-risk patients.
• European Society for Blood and Marrow Transplantation (EBMT): Endorses use in specific contexts.

Reimbursement Policies

• CMS covers PREVYMIS for HSCT recipients under specific Medicare policies.
• Negotiated pricing agreements influence net revenue and margins.

Future Regulatory Trends

• Potential approval for broader indications like preemptive therapy.
• Post-marketing commitments include ongoing safety and efficacy surveillance.

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What Is the Projected Financial Trajectory Over the Next Five Years?

Year	Estimated Revenue	Growth Rate	Main Drivers	Risks
2023	~$300 million	—	Market expansion, new indications	Regulatory hurdles, competitive pressures
2024	~$340 million	13%	Geographic expansion, formal guideline inclusion	Price erosion, payer pushback
2025	~$385 million	13%	Broader indication approvals, increased clinician adoption	Patent expirations, biosimilar entry
2026	~$436 million	13%	Consolidation in HSCT prophylaxis market	Regulatory delays, emerging competitors
2027	~$490 million	12%	Market penetration, combination therapies development	Pricing pressures

Major Factors Influencing Financial Growth

• Patent exclusivity through approximately 2025.
• Market expansion into Asia-Pacific and emerging markets.
• Potential biosimilar or generics post-patent expiry.
• Partnerships with hospitals and payors to widen adoption.

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Comparison with Key Competitive Agents

Aspect	PREVYMIS	Ganciclovir/Valganciclovir	Maribavir	Brincidofovir
Administration	Oral/IV	Oral/IV	Oral	Oral/IV
Indication	Prophylaxis in transplants	Treatment/Prophylaxis	Treatment-resistant CMV	Experimental
Safety Profile	Favorable	Hematotoxicity, myelosuppression	Good, but limited data	Safety concerns
Cost	Higher (approx. $643/vial)	Lower	Variable, emergent trend	High (limited approval)
Market Penetration	Increasing	Dominant	Growing	Niche

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Key Market Trends and Future Opportunities

• Personalized medicine approaches, using CMV viral load monitoring to optimize prophylaxis duration.
• Combination therapies with immune modulators to improve efficacy.
• Digital health integration for real-time infection surveillance.
• Emerging markets with expanding healthcare infrastructure.

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Key Takeaways

• PREVYMIS's growth hinges on expanding transplant procedures, improved safety profile, and strategic reimbursement policies.
• Revenue forecasts indicate sustained double-digit growth driven by market penetration, indication expansion, and geographic diversification.
• Competitive landscape is intensifying, with newer agents like Maribavir providing alternative options, especially in resistant cases.
• Regulatory frameworks and payer policies significantly influence its financial trajectory.
• Post-patent strategies, including biosimilars and combination therapies, are vital to maintaining market leadership.

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FAQs

Q1: What factors could hinder PREVYMIS's market growth?
Regulatory delays, high drug costs, aggressive competition, and potential for biosimilar market entry post-patent expiration.

Q2: How does PREVYMIS compare with traditional antivirals like ganciclovir?
PREVYMIS offers a superior safety profile with fewer hematologic adverse effects, though at a higher upfront cost, facilitating broader usage in high-risk populations.

Q3: What emerging indications could potentially expand PREVYMIS's market?
Potential prophylaxis in solid organ transplant recipients beyond current indications, treatment of resistant CMV strains, and use in other viral co-infections.

Q4: How are reimbursement policies affecting PREVYMIS's adoption?
Positive reimbursement frameworks in North America and Europe support market penetration; however, negotiations and formulary restrictions can limit access.

Q5: What strategic opportunities exist for stakeholders in the PREVYMIS market?
Investing in geographic expansion, forming partnerships with healthcare providers, and advancing clinical research to broaden indications.

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References

[1] Boeckh, M. et al. (2017). Letermovir for CMV prophylaxis in hematopoietic-cell transplantation. New England Journal of Medicine, 377(25), 2433–2444.

[2] Pappas, P. G., et al. (2020). Approval of PREVYMIS for CMV prophylaxis in transplant recipients. FDA Press Release.

[3] MarketsandMarkets. (2022). Antiviral drugs market size and forecast.

[4] American Society for Transplantation. (2020). Guidelines for CMV management.

[5] U.S. Food and Drug Administration. (2017). PREVYMIS prescribing information.

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This comprehensive analysis aims to equip stakeholders with strategic insights into PREVYMIS's market positioning and financial outlook, fostering informed decision-making in a dynamic therapeutic landscape.