Orange Book product · Brand (NDA)
AKYNZEO
NETUPITANT; PALONOSETRON HYDROCHLORIDE
At a glance
Oct 10, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 10, 2014
11 yr 10 mo ago
Today
Patent 11559523 expires
Listed drug product patent expiration.
Nov 18, 2030
in 4 yr 6 mo
Patent 12042494 expires
Listed drug product patent expiration.
Nov 18, 2030
in 4 yr 6 mo
Patent 8623826 expires
Listed method-of-use patent (U-2293) expiration.
Nov 18, 2030
in 4 yr 6 mo
Patent 8951969 expires
Listed drug product patent expiration.
Nov 18, 2030
in 4 yr 6 mo
Patent 9186357 expires
Listed method-of-use patent (U-2293) expiration.
Nov 18, 2030
in 4 yr 6 mo
Patent 9943515 expires
Listed method-of-use patent (U-2293) expiration.
Nov 18, 2030
in 4 yr 6 mo
Patent 10828297 expires
Listed method-of-use patent (U-2293) expiration.
Dec 17, 2030
in 4 yr 7 mo
Patent 9271975 expires
Listed method-of-use patent (U-2293) expiration.
Sep 09, 2031
in 5 yr 4 mo
Patent 10233154 expires
Listed drug substance patent expiration.
Sep 25, 2035
in 9 yr 5 mo
Patent 10676440 expires
Listed drug substance patent expiration.
Sep 25, 2035
in 9 yr 5 mo
Patent 10961195 expires
Listed drug substance patent expiration.
Sep 25, 2035
in 9 yr 5 mo
Patent 9951016 expires
Listed drug substance patent expiration.
Sep 25, 2035
in 9 yr 5 mo
Pharmaceutical detail
Active ingredient
NETUPITANT; PALONOSETRON HYDROCHLORIDE
Strength
300MG;EQ 0.5MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 205718
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11559523 | Nov 18, 2030 | in 4 yr 6 mo | ProductU-3522 |
| 12042494 | Nov 18, 2030 | in 4 yr 6 mo | ProductU-3522 |
| 8623826 | Nov 18, 2030 | in 4 yr 6 mo | U-2293 |
| 8951969 | Nov 18, 2030 | in 4 yr 6 mo | Product |
| 9186357 | Nov 18, 2030 | in 4 yr 6 mo | U-2293 |
| 9943515 | Nov 18, 2030 | in 4 yr 6 mo | U-2293 |
| 10828297 | Dec 17, 2030 | in 4 yr 7 mo | U-2293 |
| 9271975 | Sep 09, 2031 | in 5 yr 4 mo | U-2293 |
| 10233154 | Sep 25, 2035 | in 9 yr 5 mo | Substance |
| 10676440 | Sep 25, 2035 | in 9 yr 5 mo | SubstanceProduct |
| 10961195 | Sep 25, 2035 | in 9 yr 5 mo | SubstanceProduct |
| 9951016 | Sep 25, 2035 | in 9 yr 5 mo | SubstanceProduct |

