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PREVYMIS

Letermovir · Injection, Solution

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
Injection, Solution
Route
Intravenous
Marketing category
NDA · NDA
Labeler
Merck Sharp & Dohme LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
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 20 mg/mL 1988652 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Intravenous
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
209940
Application type
NDA · New Drug Application
Approval date
November 8, 2017
Sponsor
MERCK SHARP DOHME
Products on application
2
Submissions recorded
10
Products approved under application 209940.
Product Trade name Form Strength Ingredient Status TE Flags
209940-001 PREVYMIS SOLUTION LETERMOVIR Prescription — RLD RS
209940-002 PREVYMIS SOLUTION 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 April 29, 2020
RE46791 January 18, 2029 002 Yes April 29, 2020
10603384 February 28, 2033 001 No April 29, 2020
10603384 February 28, 2033 002 No April 29, 2020
Regulatory exclusivity periods.
Code Expires Product
I-916 June 5, 2026 001
I-916 June 5, 2026 002
D-189 August 2, 2026 001
D-189 August 2, 2026 002
NPP August 30, 2027 001
NPP August 30, 2027 002
ODE-423 June 5, 2030 001
ODE-423 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 209940.
Type No. Action Status Date Review
Supplement 15 Labeling Approved January 30, 2025 Standard
Supplement 16 Efficacy Approved August 30, 2024 Priority
Supplement 12 Efficacy Approved August 30, 2024 Priority
Supplement 10 Efficacy Approved August 2, 2023 Standard
Supplement 11 Efficacy Approved June 5, 2023 Priority
Supplement 6 Labeling Approved March 23, 2020 Standard
Supplement 4 Labeling Approved December 20, 2019 Standard
Supplement 3 Labeling Approved August 29, 2019 Standard
Supplement 1 Labeling Approved March 5, 2019 Standard
Original application 1 Type 3 - New Dosage Form Approved November 8, 2017 Priority

Review documents

  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 5, 2025
  • 0 · Supplement · October 15, 2024
  • 0 · Supplement · October 15, 2024
  • 0 · Supplement · September 3, 2024
  • 0 · Supplement · September 3, 2024
  • 0 · Supplement · August 4, 2023
  • 0 · Supplement · August 3, 2023
  • 0 · Supplement · June 6, 2023
  • 0 · Supplement · June 6, 2023
  • 0 · Supplement · March 24, 2020
  • 0 · Supplement · March 24, 2020
  • 0 · Supplement · December 26, 2019
  • 0 · Supplement · December 23, 2019
  • 0 · Supplement · September 3, 2019
  • 0 · Supplement · August 30, 2019
  • 0 · Supplement · March 7, 2019
  • 0 · Supplement · March 7, 2019
  • 0 · Original application · December 18, 2017
  • 0 · Original application · November 8, 2017
  • 0 · Original application · November 8, 2017

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
0006-5003-01 0006-5003 Merck Sharp & Dohme LLC 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01) / 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02) November 8, 2017
0006-5004-01 0006-5004 Merck Sharp & Dohme LLC 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5004-01) / 24 mL in 1 VIAL, SINGLE-DOSE (0006-5004-02) November 8, 2017
0006-5003 0006-5003 Merck Sharp & Dohme LLC — November 8, 2017
0006-5004 0006-5004 Merck Sharp & Dohme LLC — November 8, 2017

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.