FDA Orange Book · active-ingredient family
Allopurinol; lesinurad
Allopurinol; lesinurad is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DUZALLO · NDA 209203
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DUZALLORLD×2 | IRONWOOD PHARMS INC | NDA 209203 | — | Aug 18, 2017 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8283369 | Nov 26, 2028 | in 2 yr 6 mo | U-2104 |
| 10183012 | 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 |
Allopurinol; lesinurad — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
