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 and one Paragraph IV challenge.

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 Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

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

Constraining patent/regulatory exclusivity:

10,603,384

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

Paragraph IV (Patent) Challenges for PREVYMIS

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 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	RE46791		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
Msd	PREVYMIS	letermovir	PELLETS;ORAL	219104-002	Aug 30, 2024		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	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 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
Brazil	112014020946
Mexico	369666	COMPOSICION FARMACEUTICA QUE CONTIENE UN DERIVADO DE DIHIDROQUINAZOLINA ANTIVIRALMENTE ACTIVO. (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE.)
Portugal	2819648
Russian Federation	2360912	ЗАМЕЩЕННЫЕ ДИГИДРОХИНАЗОЛИНЫ С ПРОТИВОВИРУСНЫМИ СВОЙСТВАМИ (SUBSTITUTED DIHYDROQUINAZOLINES HAVING ANTIVIRAL PROPERTIES)
Lithuania	3556350
Slovenia	3556350
Norway	333265

Supplementary Protection Certificates for PREVYMIS

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

Market Dynamics and Financial Trajectory for PREVYMIS

Last updated: February 19, 2026

What Is the Market Position of PREVYMIS?

PREVYMIS (Letermovir) is an antiviral drug developed by Merck & Co. Inc. approved in November 2017 for prophylaxis of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant (HSCT) recipients. CMV poses a significant risk in immunocompromised patients, creating a consistent demand for effective prophylactics.

The drug's competitive advantage lies in its targeted mechanism, high efficacy, and favorable safety profile relative to existing CMV therapies. It is the first approved drug in its class, which limits competition but faces potential generic threats after patent expiry.

How Does the Current Market Landscape Look?

Market Size and Forecast

The global CMV prophylaxis market was valued at approximately USD 900 million in 2022. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 7% to reach USD 1.4 billion by 2030.

Year	Market Value (USD million)	Growth Rate
2022	900	—
2025	1,095	8.4%
2030	1,400	8.4%

Key Drivers

• Increasing Transplant Procedures: Annual HSCT procedures are rising globally, driven by expanding indications for stem cell therapy. The global HSCT market was USD 2.14 billion in 2021, expected to grow at 5% CAGR.
• Unmet Medical Needs: Limited prophylactic options with high safety and tolerability profiles boost PREVYMIS's sales potential.
• Technological Advances: Development in personalized medicine and biomarker-driven approaches enhances prophylaxis strategies.

Competitive Environment

Other drugs in this space include ganciclovir, valganciclovir, and foscarnet, but PREVYMIS's safety profile provides a competitive edge. Its high cost limits widespread use in less critical cases.

Patent and Generic Landscape

Merck's patent protection for PREVYMIS is valid until at least 2032. After patent expiry, generic competition could erode market share, potentially halving sales within five years.

What Are the Revenue Trends and Forecasts?

Historical Revenue Data

Merck disclosed that PREVYMIS generated USD 81 million in sales in the fiscal year 2022, reflecting steady growth from USD 61 million in 2020. The growth correlated with increased adoption in transplant centers and expanded indications.

Future Revenue Projections

Forecasts suggest a CAGR of 12–15% through 2025, driven by:

• Expanded use in prophylaxis protocols.
• Geographic expansion into emerging markets.
• Line extension possibilities for other viral infections.

By 2025, revenues could reach USD 150–170 million, assuming continued market penetration and no patent challenges.

Revenue Risks

• Competitive penetration: Entry of biosimilars or alternative therapies.
• Pricing pressures: Healthcare system cost containment measures.
• Regulatory delays: Longer approval timelines in new indications or regions.

What Are the Major Risks and Opportunities?

Risks

1. Patent expirations: Loss of exclusivity around 2032.
2. Regulatory challenges: Off-label use restrictions or safety concerns.
3. Market saturation: Limited patient pool if prophylactic protocols reach maturity.
4. Pricing pressures: Cost containment policies reducing margins.

Opportunities

1. New indications: Potential for expanding to other viral prophylaxis.
2. Market expansion: Growing transplant volumes in Asia and Latin America.
3. Combination therapies: Potential for synergistic formulations or co-packaged products.
4. Line extensions: Developing formulations for outpatient administration.

How Will Pricing Trends Affect Financial Performance?

PREVYMIS's high cost reflects its targeted mechanism and favorable safety profile. Market access varies by region:

• US: Reimbursement largely via private insurers and Medicare Part D.
• Europe: Reimbursement depends on health technology assessments; pricing can be negotiated.
• Emerging Markets: Lower price points to enable access, potentially reducing margins.

Price pressures could diminish profit margins by 10–20% post-patent expiration, influencing long-term revenue forecasts.

Final Analysis

PREVYMIS is a high-growth product within the antiviral prophylaxis segment, with sustained revenue prospects until patent expiry. Key growth drivers include increasing transplant procedures and geographic expansion. Risks from generic competition, pricing pressures, and regulatory hurdles remain. Strategic expansion into new indications and markets can improve long-term financial performance.

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Key Takeaways

• The global CMV prophylaxis market will reach USD 1.4 billion by 2030 with a CAGR of approximately 7%.
• PREVYMIS generated USD 81 million in sales in 2022, with growth expected to continue until patent expiration.
• Patent protection lasts until around 2032, after which generic competition could significantly impact sales.
• Opportunities lie in expanding indications, geographic markets, and combination therapies.
• Pricing pressures and market saturation are primary risks to sustained revenue growth.

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FAQs

1. When is PREVYMIS's patent set to expire?
Expected around 2032, depending on jurisdiction and patent extensions.

2. Can PREVYMIS be used for other viral infections?
Currently approved for CMV prophylaxis in HSCT recipients; potential for expansion is under clinical investigation.

3. How competitive is the CMV prophylaxis market?
Limited, with ganciclovir and valganciclovir as primary alternatives; PREVYMIS’s safety profile offers a competitive advantage.

4. What is the expected revenue decline post-patent expiry?
Potentially up to 50% within five years of generic entry.

5. Are there any regulatory hurdles that could affect PREVYMIS’s future?
Possible delays in approval for new indications or regions; ongoing safety assessments are also a factor.

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References

[1] MarketWatch. (2023). CMV prophylaxis market size and forecast.
[2] Merck & Co. Annual Reports 2022.
[3] Global Data. (2022). Hematopoietic stem cell transplantation market report.
[4] IQVIA. (2022). Pharmaceutical pricing and reimbursement insights.