Orange Book product · Brand (NDA)
DUZALLO
ALLOPURINOL; LESINURAD
At a glance
Aug 18, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 18, 2017
9 yr ago
Today
Patent 10183012 expires
Listed method-of-use patent (U-2104) expiration.
Nov 26, 2028
in 2 yr 6 mo
Patent 8283369 expires
Listed method-of-use patent (U-2104) expiration.
Nov 26, 2028
in 2 yr 6 mo
Patent 8546437 expires
Listed method-of-use patent (U-2104) expiration.
Apr 29, 2029
in 2 yr 11 mo
Patent 8084483 expires
Listed method-of-use patent (U-2104) 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 9216179 expires
Listed method-of-use patent (U-2104) expiration.
Aug 01, 2031
in 5 yr 2 mo
Patent 9956205 expires
Listed method-of-use patent (U-2104) 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
ALLOPURINOL; LESINURAD
Strength
200MG;200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209203
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 (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10183012 | Nov 26, 2028 | in 2 yr 6 mo | U-2104 |
| 8283369 | Nov 26, 2028 | in 2 yr 6 mo | U-2104 |
| 8546437 | Apr 29, 2029 | in 2 yr 11 mo | U-2104 |
| 8084483 | Aug 17, 2029 | in 3 yr 3 mo | U-2104 |
| 8357713 | Dec 22, 2029 | in 3 yr 7 mo | ProductU-2104 |
| 9216179 | Aug 01, 2031 | in 5 yr 2 mo | U-2104 |
| 9956205 | Dec 28, 2031 | in 5 yr 7 mo | U-2104 |
| 8546436 | Feb 29, 2032 | in 5 yr 9 mo | Substance |
