Orange Book product · Brand (NDA)
REZDIFFRA
RESMETIROM
At a glance
Mar 14, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 14, 2024
2 yr 4 mo ago
Today
Patent 7452882 expires
Listed drug substance patent expiration.
Sep 12, 2026
in 3 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 14, 2029
in 2 yr 9 mo
Patent 10376517 expires
Listed method-of-use patent (U-3861) expiration.
Sep 17, 2033
in 7 yr 4 mo
Patent 11564926 expires
Listed drug substance patent expiration.
Sep 17, 2033
in 7 yr 4 mo
Patent 11986481 expires
Listed method-of-use patent (U-3861) expiration.
Sep 17, 2033
in 7 yr 4 mo
Patent 9266861 expires
Listed drug substance patent expiration.
Sep 17, 2033
in 7 yr 4 mo
Patent 12377104 expires
Listed method-of-use patent (U-3861) expiration.
Feb 04, 2045
in 18 yr 11 mo
Pharmaceutical detail
Active ingredient
RESMETIROM
Strength
60MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217785
Product number
001
Marketing status
RX
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.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Mar 14, 2029
in 2 yr 9 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7452882 | Sep 12, 2026 | in 3 mo | SubstanceProduct |
| 10376517 | Sep 17, 2033 | in 7 yr 4 mo | U-3861 |
| 11564926 | Sep 17, 2033 | in 7 yr 4 mo | SubstanceProductU-3861 |
| 11986481 | Sep 17, 2033 | in 7 yr 4 mo | U-3861 |
| 9266861 | Sep 17, 2033 | in 7 yr 4 mo | SubstanceProduct |
| 12377104 | Feb 04, 2045 | in 18 yr 11 mo | U-3861 |
