Is there a generic for Letermovir?

The FDA Orange Book does not currently list an approved generic (ANDA) for Letermovir. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Letermovir?

PREVYMIS (NDA 219104, MSD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Letermovir?

The Orange Book lists 2 patents against Letermovir products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Letermovir have FDA marketing exclusivity?

Yes. The Orange Book records 32 marketing-exclusivity periods for Letermovir. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Letermovir are approved?

Letermovir is approved in the following dosage forms: pellets, solution, tablet.

FDA Orange Book · active-ingredient family

Letermovir

Letermovir is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PREVYMIS · NDA 219104

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · pellets, solution, tablet

Product	Applicant	Application	TE	Approved
PREVYMISRLD×2	MSD	NDA 219104	—	Aug 30, 2024
PREVYMISRLD×2	MERCK SHARP DOHME	NDA 209940	—	Nov 08, 2017
PREVYMISRLD×2	MERCK SHARP DOHME	NDA 209939	—	Nov 08, 2017

Marketing exclusivity (32)

NPNew product exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
ODE*FDA marketing exclusivity
Jun 05, 2030
in 4 yr
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
NPNew product exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
ODE*FDA marketing exclusivity
Jun 05, 2030
in 4 yr
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 1 mo
I-916New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
ODE-423Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 4 yr
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 1 mo
I-916New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
ODE-423Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 4 yr
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 1 mo
I-916New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
ODE-423Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 4 yr
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 1 mo
I-916New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
ODE-423Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 4 yr
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE46791	Jan 18, 2029	in 2 yr 7 mo	SubstanceProduct
10603384	Feb 28, 2033	in 6 yr 10 mo	Product

Letermovir — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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