oxycodone · Collegium Pharm Inc · NDA 208090
Xtampza Er
Earliest generic entry, as listed · earliest of 5 marketed strengths
2 Sep 2036
Blocked by patent: US 10188644, US 10646485, US 9737530, US 9968598.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10188644 | drug product, use U-1556 · sets the listed date | 2 Sep 2036 |
| US 10646485 | drug product, use U-1556 · sets the listed date | 2 Sep 2036 |
| US 9737530 | drug product, use U-1556 · sets the listed date | 2 Sep 2036 |
| US 9968598 | drug product, use U-1556 · sets the listed date | 2 Sep 2036 |
| US 10004729 | drug product, use U-1556 | 10 Dec 2030 |
| US 10668060 | drug product, use U-1556 | 10 Dec 2030 |
| US 9682075 | drug product, use U-1556 | 10 Dec 2030 |
| US 7771707 | drug product | 9 Oct 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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208090 · 001 · RLD | capsule, extended release, oral | 9MG | 2 Sep 2036 |
| 208090 · 002 · RLD | capsule, extended release, oral | 13.5MG | 2 Sep 2036 |
| 208090 · 003 · RLD | capsule, extended release, oral | 18MG | 2 Sep 2036 |
| 208090 · 004 · RLD | capsule, extended release, oral | 27MG | 2 Sep 2036 |
| 208090 · 005 · RLD | capsule, extended release, oral | 36MG | 2 Sep 2036 |