lesinurad · Ironwood Pharms Inc · NDA 207988
Zurampic
Earliest generic entry, as listed
29 Feb 2032
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8546436.
Listed patents · 8 unexpired
11 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8546436 | drug substance, drug product · sets the listed date | 29 Feb 2032 |
| US 9956205 | use U-2311 | 28 Dec 2031 |
| US 9216179 | use U-1806 | 1 Aug 2031 |
| US 8357713 | drug product, use U-1801, U-1802, U-1803 | 22 Dec 2029 |
| US 8357713 listing row | drug product, use U-1801 | 22 Dec 2029 |
| US 8357713 listing row | drug product, use U-1802 | 22 Dec 2029 |
| US 8357713 listing row | drug product, use U-1803 | 22 Dec 2029 |
| US 8084483 | use U-1801 | 17 Aug 2029 |
| US 8546437 | use U-1803 | 29 Apr 2029 |
| US 10183012 | use U-2311 | 26 Nov 2028 |
| US 8283369 | use U-1802, U-1804 | 26 Nov 2028 |
| US 8283369 listing row | use U-1802 | 26 Nov 2028 |
| US 8283369 listing row | use U-1804 | 26 Nov 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207988 · 001 · RLD · discontinued | tablet, oral | 200MG | 29 Feb 2032 |