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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 Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this drug.

This drug has eighty-seven patent family members in forty-six 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 June 5, 2030. 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:	87
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	7
Patent Applications:	127
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:

FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])

NDA:

209939

Dosage:

TABLET;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

Anatomical Therapeutic Chemical (ATC) Classes for PREVYMIS

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for PREVYMIS

PREVYMIS is protected by three US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT 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.

Patents protecting PREVYMIS

FDA Regulatory Exclusivity protecting PREVYMIS

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			Y	Y
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017		RX	Yes	No
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	Nov 8, 2017		RX	Yes	Yes

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

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
Colombia	5700764	DIHIDROQUINAZOLINAS SUSTITUIDAS CON PROPIEDADES ANTIVIRALES
Denmark	1622880
Ukraine	111415	ФАРМАЦЕВТИЧНИЙ ПРЕПАРАТ, ЩО МІСТИТЬ ПОХІДНУ ДИГІДРОХІНАЗОЛІНУ З ПРОТИВІРУСНОЮ АКТИВНІСТЮ (PHARMACEUTICAL PREPARATION CONTAINING DIHYDROQUINAZOLINE DERIVATIVE POSSESSING ANTIVIRAL ACTIVITY)
China	1784390	Substituted dihydrochinazolines having antiviral properties
Denmark	3556350
World Intellectual Property Organization (WIPO)	2004096778

Supplementary Protection Certificates for PREVYMIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1622880	SPC/GB18/027	United Kingdom		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	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	LUC00070	Luxembourg		PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU71/17/1245 20180110
1622880	122018000080	Germany		PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; REGISTRATION NO/DATE: EU/1/17/1245 20180108
1622880	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	LUC00080	Luxembourg		PRODUCT NAME: LETERMOVIR, OU UN SEL, SOLVATE OU SOLVATE DE SON SEL; AUTHORISATION NUMBER AND DATE: /EU/1/17/1245 20180110