Orange Book product · Brand (NDA)
LONSURF
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
At a glance
Sep 22, 2015
Approved
Brand (NDA)
Application
AB
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 22, 2015
10 yr 11 mo ago
Exclusivity ends · ODE-229
Orphan-drug exclusivity (7 years)
Feb 22, 2026
4 mo ago
Today
Patent RE46284 expires
Listed method-of-use patent (U-2503) expiration.
Sep 22, 2029
in 3 yr 4 mo
Patent RE46284 expires
Listed method-of-use patent (U-1751) expiration.
Sep 22, 2029
in 3 yr 4 mo
Patent RE46284 expires
Listed method-of-use patent (U-3656) expiration.
Sep 22, 2029
in 3 yr 4 mo
Patent 10457666 expires
Listed drug substance patent expiration.
Jun 17, 2034
in 8 yr 1 mo
Patent 9527833 expires
Listed drug substance patent expiration.
Jun 17, 2034
in 8 yr 1 mo
Patent 9943537 expires
Listed method-of-use patent (U-3659) expiration.
Sep 05, 2034
in 8 yr 4 mo
Patent 10456399 expires
Listed method-of-use patent (U-3657) expiration.
Feb 03, 2037
in 10 yr 9 mo
Patent 10456399 expires
Listed method-of-use patent (U-3658) expiration.
Feb 03, 2037
in 10 yr 9 mo
Patent 10960004 expires
Listed method-of-use patent (U-3657) expiration.
Feb 03, 2037
in 10 yr 9 mo
Patent 10960004 expires
Listed method-of-use patent (U-3658) expiration.
Feb 03, 2037
in 10 yr 9 mo
Pharmaceutical detail
Active ingredient
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Strength
EQ 6.14MG BASE;15MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 207981
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)
- ODE-229Orphan-drug exclusivity (7 years)
Feb 22, 2026
4 mo ago
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE46284 | Sep 22, 2029 | in 3 yr 4 mo | U-2503 |
| RE46284 | Sep 22, 2029 | in 3 yr 4 mo | U-1751 |
| RE46284 | Sep 22, 2029 | in 3 yr 4 mo | U-3656 |
| 10457666 | Jun 17, 2034 | in 8 yr 1 mo | SubstanceProduct |
| 9527833 | Jun 17, 2034 | in 8 yr 1 mo | SubstanceProduct |
| 9943537 | Sep 05, 2034 | in 8 yr 4 mo | U-3659 |
| 10456399 | Feb 03, 2037 | in 10 yr 9 mo | U-3657 |
| 10456399 | Feb 03, 2037 | in 10 yr 9 mo | U-3658 |
| 10960004 | Feb 03, 2037 | in 10 yr 9 mo | U-3657 |
| 10960004 | Feb 03, 2037 | in 10 yr 9 mo | U-3658 |
