Letermovir - Generic Drug Details

What are the generic 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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Letermovir has ninety-seven patent family members in forty-seven countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for letermovir

International Patents:	97
US Patents:	3
Tradenames:	1
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	25
Patent Applications:	270
What excipients (inactive ingredients) are in letermovir?	letermovir excipients list
DailyMed Link:	letermovir at DailyMed

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

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-])

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

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
Merck Sharp & Dohme LLC	Phase 2
University of Pennsylvania	Phase 2
Maimónides Biomedical Research Institute of Córdoba	Phase 2

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

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	209940-001	Nov 8, 2017		RX	Yes	Yes			Y	Y
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes			Y	Y
Msd	PREVYMIS	letermovir	PELLETS;ORAL	219104-002	Aug 30, 2024		RX	Yes	Yes

Expired US Patents for letermovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	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

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/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 letermovir

Country	Patent Number	Title	Estimated Expiration
Colombia	7061076	Composición farmacéutica que contiene un derivado de dihidroquinazolina antiviralmente activo
Ecuador	SP056138	DIHIDROQUINAZOLINAS SUSTITUIDAS
Malaysia	172310	PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE

Supplementary Protection Certificates for letermovir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	2018C/025	Belgium		PRODUCT NAME: LETERMOVIR, DESGEWENST IN DE VORM VAN EEN ZOUT OF SOLVAAT ERVAN OF EEN SOLVAAT VAN EEN ZOUT; AUTHORISATION NUMBER AND DATE: EU/1 /1 7/1245 20170110