Drug

Letermovir

As of the edition of 20 October 2026, Letermovir is a small molecule: marketed, first approved in 2017 (CA); US protection ends in 2031.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2022
Kind
Small molecule
Brand name
Prevymis
First approved
1 November 2017 (CA)
Approvals on record
19 in 6 regions
Holder of the most recent approval
Merck & Co.
Registered trials
48, 1 stopped early
Disease areas
Infections; Blood and lymph; Cancer; Immune system; Urinary and reproductive; Heart and blood vessels

US protection

US protection ends in 2031.

The last listed US exclusivity ends in 2031. The application that gives this date is held by Merck & Co..

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

38 listings count towards this date. The exact date and each listing are in the product.

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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated9330
Phase 14130
Phase 217671
Phase 313660
Phase 45130
All trials48

Who has held its approvals

CompanyRoleYears
Merck & Co.Applicant and Lead sponsor of trials2014 to now