Orange Book product · Brand (NDA)
ZEPATIER
ELBASVIR; GRAZOPREVIR
Brand (NDA)NDA 208261DISCN MSD SUB MERCK
At a glance
Jan 28, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 28, 2016
10 yr 7 mo ago
Today
Patent 7973040 expires
Listed drug substance patent expiration.
Jul 24, 2029
in 3 yr 2 mo
Patent 8871759 expires
Listed drug substance patent expiration.
May 04, 2031
in 4 yr 11 mo
Pharmaceutical detail
Active ingredient
ELBASVIR; GRAZOPREVIR
Strength
50MG;100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208261
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7973040 | Jul 24, 2029 | in 3 yr 2 mo | SubstanceProductU-1813 |
| 8871759 | May 04, 2031 | in 4 yr 11 mo | SubstanceProductU-1813 |
