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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 three patents protecting this drug.

This drug has ninety-seven patent family members in forty-seven 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:	97
US Patents:	3
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	7
Patent Applications:	105
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
Children's Oncology Group	Phase 3
Jean-Pierre Routy	N/A
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2

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 three US patents and ten 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	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
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	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	209939-002	Nov 8, 2017
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	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/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 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

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
Serbia	65137	FARMACEUTSKI PREPARAT KOJI OBUHVATA ANTIVIRUSNO EFIKASAN DERIVAT DIHIDROHINAZOLINA SA S KONFIGURACIJOM U POLOŽAJU 4 (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE WITH S CONFIGURATION IN POSITION 4)
Spain	2284007
Brazil	PI0410029	dihidroquinazolinas substituìdas
European Patent Office	3556350	PRÉPARATION PHARMACEUTIQUE COMPRENANT UNE DÉRIVÉ ANTIVIRALE DE DIHYDROQUINAZOLINE AVEC UNE CONFIGURATION DE "S" A LA POSITION 4 (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE WITH S CONFIGURATION IN POSITION 4)

Supplementary Protection Certificates for PREVYMIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	327 50010-2018	Slovakia		OWNER(S): AIC246 GMBH&CO. KG, WUPPERTAL, DE; PREVIOUS OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, WUPPERTAL, DE;

PREVYMIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PREVYMIS

Introduction

PREVYMIS (letermovir), developed by Merck, is a groundbreaking drug in the treatment and prevention of cytomegalovirus (CMV) infections, particularly in transplant recipients. This article delves into the market dynamics and financial trajectory of PREVYMIS, highlighting its approval process, market impact, and financial performance.

Approval and Regulatory Milestones

PREVYMIS has received significant regulatory approvals that have bolstered its market position. The U.S. FDA granted priority review for the supplemental new drug application (sNDA) for PREVYMIS for the prophylaxis of CMV disease in adult kidney transplant recipients at high risk, with a target action date of June 5, 2023[1].

Additionally, the FDA accepted another sNDA to extend the use of PREVYMIS from 100 days to 200 days in adults receiving an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease, with a PDUFA date of September 7, 2023[1].

Market Impact

Patient Need and Risk

CMV infection is a serious concern for transplant recipients, particularly those who are CMV-seronegative and receive an organ from a CMV-seropositive donor (D+/R-). PREVYMIS addresses this critical need by providing a prophylactic treatment that significantly reduces the risk of CMV disease, thereby improving patient outcomes and reducing the risk of transplant failure and death[1].

Competitive Landscape

The cytomegalovirus infections market is expected to exhibit moderate growth by 2032, driven by the launch of novel therapies. PREVYMIS, as a first-in-class non-nucleoside CMV inhibitor, holds a unique position in this market. Other key players, such as ModernaTX, Inc., GlaxoSmithKline, and AlloVir, are also developing innovative treatments, but PREVYMIS's approval and efficacy make it a leading contender[4].

Global Approval and Adoption

PREVYMIS is approved in more than 60 countries, including the United States, EU member states, Canada, Japan, and China. This widespread approval has facilitated its global adoption and contributed to its strong sales performance[1].

Financial Performance

Sales Growth

PREVYMIS has shown robust sales growth driven by strong global demand. In the Q2 2022 earnings report, PREVYMIS sales grew by 18%, reflecting continued strong global demand for the drug[5].

Contribution to Merck's Revenue

The success of PREVYMIS is part of Merck's broader financial success. Merck's human health revenues, which include PREVYMIS, have seen significant growth. For instance, in the Q1 2020 earnings report, Merck's hospital business benefited from growth in PREVYMIS, among other products[3].

Overall Financial Outlook

Merck's financial outlook for 2024 anticipates worldwide sales to be between $62.7 billion and $64.2 billion, with non-GAAP EPS expected to be between $8.44 and $8.59. While PREVYMIS is not the only contributor to these figures, its growing sales and expanding indications are crucial components of Merck's overall financial performance[2].

Market Size and Growth Projections

The cytomegalovirus infections market is projected to grow significantly by 2032, driven by the launch of novel therapies. According to DelveInsight, the market size for CMV infections across the 7MM (the United States, EU-4, the United Kingdom, and Japan) is expected to grow with a significant CAGR by 2032. The overall diagnosed population of CMV infections in the 7MM was reported as 111K in 2022, indicating a substantial market potential for PREVYMIS and other CMV treatments[4].

Industry Expert Insights

Dr. Nicholas Kartsonis, senior vice president of vaccines and infectious diseases at Merck Research Laboratories, highlighted the importance of PREVYMIS: "Certain high-risk individuals who develop CMV infection following receipt of a kidney transplant are at increased risk for transplant failure and death. PREVYMIS has the potential to be an important new option with a favorable safety profile for patients at risk for CMV infection following a kidney transplant"[1].

Competitive Advantage

PREVYMIS's mechanism of action, inhibiting viral replication by targeting the viral terminase complex, makes it a unique and effective treatment. It is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors, reducing the likelihood of cross-resistance with other antiviral drugs[1].

Future Outlook

The future outlook for PREVYMIS is promising, given its expanding indications and strong market demand. As the cytomegalovirus infections market continues to grow, PREVYMIS is well-positioned to remain a leading treatment option. Merck's ongoing investments in clinical trials and pipeline development will further enhance the drug's market presence.

Key Takeaways

• Regulatory Approvals: PREVYMIS has received priority review for its sNDA for prophylaxis of CMV disease in high-risk kidney transplant recipients and for extending its use in HSCT recipients.
• Market Impact: PREVYMIS addresses a critical need in preventing CMV infections in transplant recipients, reducing the risk of transplant failure and death.
• Financial Performance: PREVYMIS has shown robust sales growth, contributing to Merck's overall financial success.
• Market Size and Growth: The CMV infections market is projected to grow significantly by 2032, driven by novel therapies.
• Competitive Advantage: PREVYMIS's unique mechanism of action and favorable safety profile make it a leading treatment option.

FAQs

What is PREVYMIS used for?

PREVYMIS (letermovir) is used for the prophylaxis of cytomegalovirus (CMV) infection and disease in adults who are CMV-seropositive and have received an allogeneic hematopoietic stem cell transplant (HSCT) or are high-risk kidney transplant recipients.

What is the regulatory status of PREVYMIS?

PREVYMIS has received FDA approval for its initial indication and is currently under priority review for expanded indications, including prophylaxis in high-risk kidney transplant recipients and extended use in HSCT recipients.

How does PREVYMIS work?

PREVYMIS inhibits viral replication by specifically targeting the viral terminase complex, making it a first-in-class non-nucleoside CMV inhibitor.

What is the market potential for PREVYMIS?

The cytomegalovirus infections market is expected to grow significantly by 2032, driven by the launch of novel therapies, with PREVYMIS well-positioned to capture a substantial share due to its unique mechanism and favorable safety profile.

Who are the key competitors in the CMV infections market?

Key competitors include ModernaTX, Inc., GlaxoSmithKline, and AlloVir, among others, which are also developing innovative treatments for CMV infections.

Sources

1. Merck Press Release: "U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for Merck’s PREVYMIS™ for Prophylaxis of Cytomegalovirus Disease in Kidney Transplant Recipients at High Risk"[1].
2. Merck Financial Report: "Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results"[2].
3. Merck Q1 2020 Earnings Call Transcript: "MRK - Q1 2020 Merck & Co Inc Earnings Call"[3].
4. GlobeNewswire: "Cytomegalovirus Infections Market to Exhibit Moderate Growth by 2032, Evaluates DelveInsight | Leading Companies - ModernaTX, Inc., Merck Sharp & Dohme LLC, GlaxoSmithKline, AlloVir"[4].
5. Merck Q2 2022 Earnings Deck: "Q2 2022 Merck Earnings"[5].