Orange Book product · Brand (NDA)
LITFULO
RITLECITINIB TOSYLATE
At a glance
Jun 23, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 23, 2023
3 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 23, 2028
in 2 yr 1 mo
Patent 12077533 expires
Listed method-of-use patent (U-3994) expiration.
Dec 03, 2034
in 8 yr 7 mo
Patent 9617258 expires
Listed drug substance patent expiration.
Dec 03, 2034
in 8 yr 7 mo
Patent 12116368 expires
Listed drug substance patent expiration.
Oct 17, 2041
in 15 yr 7 mo
Pharmaceutical detail
Active ingredient
RITLECITINIB TOSYLATE
Strength
EQ 50MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 215830
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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)
Jun 23, 2028
in 2 yr 1 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12077533 | Dec 03, 2034 | in 8 yr 7 mo | U-3994 |
| 9617258 | Dec 03, 2034 | in 8 yr 7 mo | SubstanceProduct |
| 12116368 | Oct 17, 2041 | in 15 yr 7 mo | Substance |
