Orange Book product · Brand (NDA)
ZURAMPIC
LESINURAD
At a glance
Dec 22, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2015
10 yr 8 mo ago
Today
Patent 10183012 expires
Listed method-of-use patent (U-2311) expiration.
Nov 26, 2028
in 2 yr 6 mo
Patent 8283369 expires
Listed method-of-use patent (U-1804) expiration.
Nov 26, 2028
in 2 yr 6 mo
Patent 8283369 expires
Listed method-of-use patent (U-1802) expiration.
Nov 26, 2028
in 2 yr 6 mo
Patent 8546437 expires
Listed method-of-use patent (U-1803) expiration.
Apr 29, 2029
in 2 yr 11 mo
Patent 8084483 expires
Listed method-of-use patent (U-1801) expiration.
Aug 17, 2029
in 3 yr 3 mo
Patent 8357713 expires
Listed drug product patent expiration.
Dec 22, 2029
in 3 yr 7 mo
Patent 8357713 expires
Listed drug product patent expiration.
Dec 22, 2029
in 3 yr 7 mo
Patent 8357713 expires
Listed drug product patent expiration.
Dec 22, 2029
in 3 yr 7 mo
Patent 9216179 expires
Listed method-of-use patent (U-1806) expiration.
Aug 01, 2031
in 5 yr 2 mo
Patent 9956205 expires
Listed method-of-use patent (U-2311) expiration.
Dec 28, 2031
in 5 yr 7 mo
Patent 8546436 expires
Listed drug substance patent expiration.
Feb 29, 2032
in 5 yr 9 mo
Pharmaceutical detail
Active ingredient
LESINURAD
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 207988
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 (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10183012 | Nov 26, 2028 | in 2 yr 6 mo | U-2311 |
| 8283369 | Nov 26, 2028 | in 2 yr 6 mo | U-1804 |
| 8283369 | Nov 26, 2028 | in 2 yr 6 mo | U-1802 |
| 8546437 | Apr 29, 2029 | in 2 yr 11 mo | U-1803 |
| 8084483 | Aug 17, 2029 | in 3 yr 3 mo | U-1801 |
| 8357713 | Dec 22, 2029 | in 3 yr 7 mo | ProductU-1801 |
| 8357713 | Dec 22, 2029 | in 3 yr 7 mo | ProductU-1803 |
| 8357713 | Dec 22, 2029 | in 3 yr 7 mo | ProductU-1802 |
| 9216179 | Aug 01, 2031 | in 5 yr 2 mo | U-1806 |
| 9956205 | Dec 28, 2031 | in 5 yr 7 mo | U-2311 |
| 8546436 | Feb 29, 2032 | in 5 yr 9 mo | SubstanceProduct |

