Letermovir - Generic Drug Details

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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

Generic Entry Dates for letermovir^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SOLUTION;INTRAVENOUS
Generic Entry Dates for letermovir^: ⤷ Sign Up* 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-]) Dosage: TABLET;ORAL
Generic Entry Dates for letermovir^: ⤷ Sign Up* 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-]) 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
University of Pennsylvania	Phase 2
Merck Sharp & Dohme LLC	Phase 2
MERCK SHARP & DOHME DE ESPAÑA S.A.	Phase 2

See all letermovir clinical trials

Generic filers with tentative approvals for LETERMOVIR

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	480MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd	PREVYMIS	letermovir	PELLETS;ORAL	219104-001	Aug 30, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	Nov 8, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-002	Nov 8, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Msd	PREVYMIS	letermovir	PELLETS;ORAL	219104-001	Aug 30, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for letermovir

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

EU/EMA Drug Approvals for letermovir

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for letermovir

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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)	⤷ Sign Up
Norway	20055649		⤷ Sign Up
Russian Federation	2360912	ЗАМЕЩЕННЫЕ ДИГИДРОХИНАЗОЛИНЫ С ПРОТИВОВИРУСНЫМИ СВОЙСТВАМИ (SUBSTITUTED DIHYDROQUINAZOLINES HAVING ANTIVIRAL PROPERTIES)	⤷ Sign Up
Spain	2741698		⤷ Sign Up
Poland	2819648		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for letermovir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1622880	2018C/025	Belgium	⤷ Sign Up	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
1622880	LUC00070	Luxembourg	⤷ Sign Up	PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU71/17/1245 20180110
1622880	C201830035	Spain	⤷ Sign Up	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/015	Belgium	⤷ Sign Up	PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU/1/17/1245 20180110
1622880	C 2018 027	Romania	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.