FDA Orange Book · active-ingredient family
Fentanyl hydrochloride
Fentanyl hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:IONSYS · NDA 021338
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · system
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IONSYSRLD | THE MEDICINES CO | NDA 021338 | — | May 22, 2006 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9364656 | Sep 30, 2031 | in 5 yr 4 mo | U-736 |
| 8301238 | Sep 30, 2031 | in 5 yr 4 mo | Product |
| 9731121 | Oct 17, 2031 | in 5 yr 5 mo | Product |
| 8781571 | Mar 31, 2032 | in 5 yr 10 mo | ProductU-736 |
| 8428708 | May 21, 2032 | in 6 yr | U-736 |
| 8428709 | Jun 11, 2032 | in 6 yr 1 mo | ProductU-736 |
| 9095706 | Feb 03, 2033 | in 6 yr 9 mo | Product |
Fentanyl hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
