Orange Book product · Brand (NDA)

PREVYMIS

LETERMOVIR

Brand (NDA)NDA 209940RX MERCK SHARP DOHME

Nov 08, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 08, 2017
8 yr 9 mo ago
Exclusivity ends · I-916
New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
Today
Exclusivity ends · D-189
New indication / change exclusivity (3 years)
Aug 02, 2026
in 1 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
Patent RE46791 expires
Listed drug substance patent expiration.
Jan 18, 2029
in 2 yr 7 mo
Exclusivity ends · ODE-423
Orphan-drug exclusivity (7 years)
Jun 05, 2030
in 4 yr
Exclusivity ends · ODE-495
Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
Exclusivity ends · ODE-497
Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
Patent 10603384 expires
Listed drug product patent expiration.
Feb 28, 2033
in 6 yr 10 mo

Active ingredient

LETERMOVIR

Strength

240MG/12ML (20MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 209940

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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