FDA Orange Book · active-ingredient family
Netupitant; palonosetron hydrochloride
Netupitant; palonosetron hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AKYNZEO · NDA 205718
1
Brand (NDA)
0
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AKYNZEORLD | HELSINN HLTHCARE | NDA 205718 | — | Oct 10, 2014 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9943515 | Nov 18, 2030 | in 4 yr 6 mo | U-2293 |
| 8623826 | Nov 18, 2030 | in 4 yr 6 mo | U-2293 |
| 9186357 | Nov 18, 2030 | in 4 yr 6 mo | U-2293 |
| 11559523 | Nov 18, 2030 | in 4 yr 6 mo | ProductU-3522 |
| 12042494 | Nov 18, 2030 | in 4 yr 6 mo | ProductU-3522 |
| 8951969 | Nov 18, 2030 | in 4 yr 6 mo | Product |
| 10828297 | Dec 17, 2030 | in 4 yr 7 mo | U-2293 |
| 9271975 | Sep 09, 2031 | in 5 yr 4 mo | U-2293 |
| 9951016 | Sep 25, 2035 | in 9 yr 5 mo | SubstanceProduct |
| 10676440 | Sep 25, 2035 | in 9 yr 5 mo | SubstanceProduct |
| 10961195 | Sep 25, 2035 | in 9 yr 5 mo | SubstanceProduct |
| 10233154 | Sep 25, 2035 | in 9 yr 5 mo | Substance |
Netupitant; palonosetron hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
