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Last Updated: November 22, 2024

LETERMOVIR - Generic Drug Details


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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 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*:
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
Generic Entry Dates for LETERMOVIR*:
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

SponsorPhase
Merck Sharp & Dohme LLCPhase 2
University of PennsylvaniaPhase 2
Maimónides Biomedical Research Institute of CórdobaPhase 2

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

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

Supplementary Protection Certificates for LETERMOVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1622880 C20180020 00265 Estonia ⤷  Sign Up PRODUCT NAME: LETERMOVIIR;REG NO/DATE: EU/1/17/1245 10.01.2018
1622880 327 50010-2018 Slovakia ⤷  Sign Up OWNER(S): AIC246 GMBH&CO. KG, WUPPERTAL, DE; PREVIOUS OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, WUPPERTAL, DE;
1622880 18C1029 France ⤷  Sign Up PRODUCT NAME: LETERMOVIR AINSI QUE SES SELS,SOLVATES ET SELS SOLVATES,PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/17/1245/001-004 20180110
1622880 122018000080 Germany ⤷  Sign Up PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; REGISTRATION NO/DATE: EU/1/17/1245 20180108
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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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