allopurinol; lesinurad · Ironwood Pharms Inc · NDA 209203
Duzallo
Earliest generic entry, as listed · earliest of 2 marketed strengths
29 Feb 2032
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8546436.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8546436 | substance | 29 Feb 2032 |
| US 9956205 | use U-2104 | 28 Dec 2031 |
| US 9216179 | use U-2104 | 1 Aug 2031 |
| US 8357713 | product, use U-2104 | 22 Dec 2029 |
| US 8084483 | use U-2104 | 17 Aug 2029 |
| US 8546437 | use U-2104 | 29 Apr 2029 |
| US 10183012 | use U-2104 | 26 Nov 2028 |
| US 8283369 | use U-2104 | 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209203 · 001 · RLD · discontinued | tablet, oral | 200MG;200MG | 29 Feb 2032 |
| 209203 · 002 · RLD · discontinued | tablet, oral | 300MG;200MG | 29 Feb 2032 |