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PREVYMIS

Letermovir · Pellet

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
PREVYMIS
Generic name
Letermovir
Dosage form
Pellet
Route
Oral
Marketing category
NDA · NDA
Labeler
Merck Sharp & Dohme LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Letermovir 120 mg/1 1988652 View
Letermovir 20 mg/1 1988652 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Pellet
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 2C19 Inducers [MoA] MoA All 37 members
Cytochrome P450 2C8 Inhibitors [MoA] MoA All 56 members
Cytochrome P450 2C9 Inducers [MoA] MoA All 46 members
Cytochrome P450 3A Inhibitors [MoA] MoA All 89 members
Cytomegalovirus DNA Terminase Complex Inhibitor [EPC] EPC 3 members — no class page
DNA Terminase Complex Inhibitors [MoA] MoA 3 members — no class page
Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA] MoA All 19 members
Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA] MoA All 10 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
219104
Application type
NDA · New Drug Application
Approval date
August 30, 2024
Sponsor
MSD
Products on application
2
Submissions recorded
2
Products approved under application 219104.
Product Trade name Form Strength Ingredient Status TE Flags
219104-001 PREVYMIS PELLETS LETERMOVIR Prescription — RLD
219104-002 PREVYMIS PELLETS LETERMOVIR Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
RE46791 January 18, 2029 001 Yes September 25, 2024
RE46791 January 18, 2029 002 Yes September 25, 2024
Regulatory exclusivity periods.
Code Expires Product
NP August 30, 2027 001
NP August 30, 2027 002
ODE* June 5, 2030 001
ODE* June 5, 2030 002
ODE-495 August 30, 2031 001
ODE-497 August 30, 2031 001
ODE-495 August 30, 2031 002
ODE-497 August 30, 2031 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 219104.
Type No. Action Status Date Review
Supplement 1 Labeling Approved January 30, 2025 Standard
Original application 1 Type 3 - New Dosage Form Approved August 30, 2024 Priority

Review documents

  • 0 · Original application · July 16, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 5, 2025
  • 0 · Original application · September 3, 2024
  • 0 · Original application · September 2, 2024

Adverse event reports

Source: openFDA FAERS
3,121
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LETERMOVIR. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0006-5085-01 0006-5085 Merck Sharp & Dohme LLC 30 PACKET in 1 CARTON (0006-5085-01) / 48 PELLET in 1 PACKET August 30, 2024
0006-5086-01 0006-5086 Merck Sharp & Dohme LLC 30 PACKET in 1 CARTON (0006-5086-01) / 8 PELLET in 1 PACKET August 30, 2024
0006-5085 0006-5085 Merck Sharp & Dohme LLC — August 30, 2024
0006-5086 0006-5086 Merck Sharp & Dohme LLC — August 30, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.