acetaminophen; oxycodone hydrochloride · Mallinckrodt Inc · NDA 204031
Xartemis Xr
Earliest generic entry, as listed
16 May 2032
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8658631, US 8741885, US 8992975, US 9050335, US 9468636.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8658631 | drug product · sets the listed date | 16 May 2032 |
| US 8741885 | drug product, use U-1499 · sets the listed date | 16 May 2032 |
| US 8992975 | drug product · sets the listed date | 16 May 2032 |
| US 9050335 | drug product · sets the listed date | 16 May 2032 |
| US 9468636 | use U-1499 · sets the listed date | 16 May 2032 |
| US 8597681 | drug product | 21 Dec 2030 |
| US 8980319 | drug product | 21 Dec 2030 |
| US 8377453 | drug product, use U-1499 | 19 Nov 2029 |
| US 8372432 | drug product, use U-1499 | 11 Mar 2029 |
| US 8394408 | drug product | 11 Mar 2029 |
| US 8668929 | use U-1499 | 11 Mar 2029 |
| US 7976870 | use U-1498 | 1 Jun 2027 |
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 |
|---|---|---|---|
| 204031 · 001 · RLD · discontinued | tablet, extended release, oral | 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 16 May 2032 |