FDA Orange Book · active-ingredient family
Oxycodone
Oxycodone is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:XTAMPZA ER · NDA 208090
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XTAMPZA ERRLD×5 | COLLEGIUM PHARM INC | NDA 208090 | — | Apr 26, 2016 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7771707 | Oct 09, 2028 | in 2 yr 4 mo | Product |
| 10004729 | Dec 10, 2030 | in 4 yr 7 mo | ProductU-1556 |
| 9682075 | Dec 10, 2030 | in 4 yr 7 mo | ProductU-1556 |
| 10668060 | Dec 10, 2030 | in 4 yr 7 mo | ProductU-1556 |
| 10188644 | Sep 02, 2036 | in 10 yr 4 mo | ProductU-1556 |
| 10646485 | Sep 02, 2036 | in 10 yr 4 mo | ProductU-1556 |
| 9968598 | Sep 02, 2036 | in 10 yr 4 mo | ProductU-1556 |
| 9737530 | Sep 02, 2036 | in 10 yr 4 mo | ProductU-1556 |
Oxycodone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
