LETERMOVIR - Generic Drug Details

What are the generic drug sources for letermovir and what is the scope of freedom to operate?

Letermovir is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Letermovir has eighty-seven patent family members in forty-six countries.

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

Summary for LETERMOVIR

International Patents:	87
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	21
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

^*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
Children's Oncology Group	Phase 3
Merck Sharp & Dohme LLC	Phase 3
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1

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

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

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
Netherlands	300933
Lithuania	2819648
India	1892MUN2014
Denmark	3556350
Chile	2014002306	Una composicion farmaceutica intravenosa que comprende al compuesto acido {8-fluoro-2-[4-(3-metoxifenil)-piperazina-1-il]-3-[2-metoxi-5-(trifluorometil)fenil]-3,4-dihidroquinazolina-4-il}acetico, al menos un excipiente seleccionado de ciclodextrinas, lisina y arginina, y agua; su metodo de preparacion; y su uso para el tratamiento y/o profilaxis de infecciones por virus.
Singapore	11201405294X	PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
China	1784390	Substituted dihydrochinazolines having antiviral properties

Supplementary Protection Certificates for LETERMOVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	132018000000381	Italy		PRODUCT NAME: LETERMOVIR, O IL SUO SALE, SOLVATO O SOLVATO DEL SUO SALE(PREVYMIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1245/001-004, 20180110
1622880	LUC00070	Luxembourg		PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU71/17/1245 20180110
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	327 50010-2018	Slovakia		OWNER(S): AIC246 GMBH&CO. KG, WUPPERTAL, DE; PREVIOUS OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, WUPPERTAL, DE;
1622880	122018000080	Germany		PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; REGISTRATION NO/DATE: EU/1/17/1245 20180108