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: 3 brands, 0 generics; first approved Nov 08, 2017; on patent until Jan 18, 2029.

On patent32 exclusivity periods

Generic status & protection

Protected until Jan 18, 2029 (earliest listed patent expiry).

Earliest patent expiry Jan 18, 2029Latest exclusivity ends Aug 30, 2031

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 18, 2029

in 2 yr 7 mo

Originator applications

Brand (NDA) products

PREVYMISRLD

MSDNDA 21910420242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG/PACKET	PELLETS	ORAL	Rx	—
120MG/PACKET	PELLETS	ORAL	Rx	—

PREVYMISRLDRS

MERCK SHARP DOHMENDA 20994020172 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
240MG/12ML (20MG/ML)	SOLUTION	INTRAVENOUS	Rx	—
480MG/24ML (20MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

PREVYMISRLD

MERCK SHARP DOHMENDA 20993920172 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
240MG	TABLET	ORAL	Rx	—
480MG	TABLET	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (32)

NPNew product exclusivity (3 years)
Aug 30, 2027
in 1 yr 2 mo
ODE*FDA marketing exclusivity
Jun 05, 2030
in 3 yr 11 mo
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
NPNew product exclusivity (3 years)
Aug 30, 2027
in 1 yr 2 mo
ODE*FDA marketing exclusivity
Jun 05, 2030
in 3 yr 11 mo
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 20 d
I-916New indication exclusivity (3 years)
Jun 05, 2026
1 mo ago
NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 2 mo
ODE-423Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 3 yr 11 mo
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 20 d
I-916New indication exclusivity (3 years)
Jun 05, 2026
1 mo ago
NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 2 mo
ODE-423Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 3 yr 11 mo
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 20 d
I-916New indication exclusivity (3 years)
Jun 05, 2026
1 mo ago
NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 2 mo
ODE-423Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 3 yr 11 mo
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 20 d
I-916New indication exclusivity (3 years)
Jun 05, 2026
1 mo ago
NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 2 mo
ODE-423Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 3 yr 11 mo
ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo
ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 2 mo

Orange Book patent file

Listed patents

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 9 mo	Product

FDA approval span

Approval history

First approval

Nov 08, 2017

8 yr 10 mo ago

Most recent approval

Aug 30, 2024

1 yr 11 mo ago

Approvals span 2017–2024 across 3 FDA applications.

Brand (NDA) 3100%

Generic (ANDA) 00%

Letermovir — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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