Orange Book product · Brand (NDA)
AKYNZEO
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
At a glance
Apr 19, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 19, 2018
8 yr 3 mo ago
Today
Patent 9186357 expires
Listed method-of-use patent (U-2301) expiration.
Nov 18, 2030
in 4 yr 6 mo
Patent 10828297 expires
Listed method-of-use patent (U-2301) expiration.
Dec 17, 2030
in 4 yr 7 mo
Patent 10208073 expires
Listed method-of-use patent (U-2301) expiration.
May 23, 2032
in 6 yr
Patent 10717721 expires
Listed drug substance patent expiration.
May 23, 2032
in 6 yr
Patent 11312698 expires
Listed drug substance patent expiration.
May 23, 2032
in 6 yr
Patent 8426450 expires
Listed drug substance patent expiration.
May 23, 2032
in 6 yr
Patent 8895586 expires
Listed method-of-use patent (U-2301) expiration.
May 23, 2032
in 6 yr
Patent 9403772 expires
Listed drug substance patent expiration.
May 23, 2032
in 6 yr
Patent 9908907 expires
Listed drug substance patent expiration.
May 23, 2032
in 6 yr
Patent 10624911 expires
Listed drug product patent expiration.
Jun 02, 2037
in 11 yr 1 mo
Patent 11529362 expires
Listed drug product patent expiration.
Jun 02, 2037
in 11 yr 1 mo
Patent 12208109 expires
Listed drug product patent expiration.
Jun 02, 2037
in 11 yr 1 mo
Pharmaceutical detail
Active ingredient
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Strength
EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 210493
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 |
|---|---|---|---|
| 9186357 | Nov 18, 2030 | in 4 yr 6 mo | U-2301 |
| 10828297 | Dec 17, 2030 | in 4 yr 7 mo | U-2301 |
| 10208073 | May 23, 2032 | in 6 yr | U-2301 |
| 10717721 | May 23, 2032 | in 6 yr | Substance |
| 11312698 | May 23, 2032 | in 6 yr | SubstanceProduct |
| 8426450 | May 23, 2032 | in 6 yr | SubstanceProduct |
| 8895586 | May 23, 2032 | in 6 yr | U-2301 |
| 9403772 | May 23, 2032 | in 6 yr | SubstanceU-2301 |
| 9908907 | May 23, 2032 | in 6 yr | SubstanceProduct |
| 10624911 | Jun 02, 2037 | in 11 yr 1 mo | Product |
| 11529362 | Jun 02, 2037 | in 11 yr 1 mo | Product |
| 12208109 | Jun 02, 2037 | in 11 yr 1 mo | Product |
