FDA Orange Book · active-ingredient family
Fosnetupitant chloride hydrochloride; palonosetron hydrochloride
Fosnetupitant chloride hydrochloride; 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 210493
1
Brand (NDA)
0
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AKYNZEORLD×2 | HELSINN HLTHCARE | NDA 210493 | — | Apr 19, 2018 |
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 |
| 8895586 | May 23, 2032 | in 6 yr | U-2301 |
| 9403772 | May 23, 2032 | in 6 yr | SubstanceU-2301 |
| 11312698 | May 23, 2032 | in 6 yr | SubstanceProduct |
| 8426450 | May 23, 2032 | in 6 yr | SubstanceProduct |
| 9908907 | May 23, 2032 | in 6 yr | SubstanceProduct |
| 10717721 | May 23, 2032 | in 6 yr | Substance |
| 12208109 | Jun 02, 2037 | in 11 yr 1 mo | Product |
| 11529362 | Jun 02, 2037 | in 11 yr 1 mo | Product |
| 10624911 | Jun 02, 2037 | in 11 yr 1 mo | Product |
Fosnetupitant chloride hydrochloride; palonosetron hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
