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Last Updated: May 24, 2024

LETERMOVIR - Generic Drug Details


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What are the generic drug sources for letermovir and what is the scope of patent protection?

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 ninety-four 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:94
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
Generic Entry Dates for LETERMOVIR*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for LETERMOVIR*:
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

SponsorPhase
Children's Oncology GroupPhase 3
Merck Sharp & Dohme LLCPhase 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
⤷  Sign Up⤷  Sign Up480MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up240MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 209940-002 Nov 8, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 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
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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
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 SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-001 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 SOLUTION;INTRAVENOUS 209940-002 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 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 209940-002 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

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

Country Patent Number Title Estimated Expiration
Denmark 2819648 ⤷  Sign Up
Canada 2865203 PREPARATION PHARMACEUTIQUE CONTENANT UN DERIVE DE DIHYDROCHINAZOLINE A ACTION ANTIVIRALE (PHARMACEUTICAL COMPOSITION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE) ⤷  Sign Up
Honduras 2004000146 DIHIDROQUINAZOLINAS SUSTITUIDAS ⤷  Sign Up
Israel 234363 תכשיר רוקחות המכיל נגזרת דיהידרוקוינאזולין עם פעילות אנטי-נגיפית (Pharmaceutical preparation containing an antivirally active dihydroquinazoline derivative) ⤷  Sign Up
Norway 2018022 ⤷  Sign Up
Montenegro 03448 FARMACEUTSKI PREPARAT КОЈI OBUHVATA ANTIVIRUSNO EFIKASAN DERIVAT DIHIDROHINAZOLINA (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY DIHYDROQUINAZOLINE DERIVATIVE) ⤷  Sign Up
Germany 10319612 Substituierte Dihydrochinazoline ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LETERMOVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1622880 LUC00080 Luxembourg ⤷  Sign Up PRODUCT NAME: LETERMOVIR, OU UN SEL, SOLVATE OU SOLVATE DE SON SEL; AUTHORISATION NUMBER AND DATE: /EU/1/17/1245 20180110
1622880 28/2018 Austria ⤷  Sign Up PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; NAT. REGISTRATION NO/DATE: EU/1/17/1245/001 - EU/1/17/1245/004 (MITTEILUNG) 20180110; FIRST REGISTRATION: EU EU/1/17/1245/001 - EU/1/17/1245/004 20180110
1622880 2018C/015 Belgium ⤷  Sign Up PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU/1/17/1245 20180110
1622880 2018/026 Ireland ⤷  Sign Up PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE, OR SOLVATE OF ITS SALT.; REGISTRATION NO/DATE: EU/1/17/1245 20180108
1622880 300933 Netherlands ⤷  Sign Up PRODUCT NAME: LETERMOVIR; REGISTRATION NO/DATE: EU/1/17/1245 20180110
1622880 C20180020 00265 Estonia ⤷  Sign Up PRODUCT NAME: LETERMOVIIR;REG NO/DATE: EU/1/17/1245 10.01.2018
>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.