FDA Orange Book · active-ingredient family
Palonosetron hydrochloride
Palonosetron hydrochloride is approved as 5 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PALONOSETRON HYDROCHLORIDE · NDA 208109
5
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PALONOSETRON HYDROCHLORIDERLD | FRESENIUS KABI USA | NDA 208109 | — | Nov 21, 2017 | |
| POSFREARLD×2 | AVYXA HOLDINGS | NDA 203050 | — | Mar 01, 2016 | |
| ALOXIRLD | HELSINN HLTHCARE | NDA 022233 | — | Aug 22, 2008 | |
| ALOXIRLD×2 | HELSINN HLTHCARE | NDA 021372 | — | Feb 29, 2008 | |
| PALONOSETRON HYDROCHLORIDE | HIKMA | NDA 207963 | — | Aug 22, 2016 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PALONOSETRON HYDROCHLORIDE | MEITHEAL | ANDA 215861 | AP | Aug 14, 2023 | |
| PALONOSETRON HYDROCHLORIDE | BAXTER HLTHCARE CORP | ANDA 206916 | AP | Nov 12, 2021 | |
| PALONOSETRON HYDROCHLORIDE×2 | AVET LIFESCIENCES | ANDA 202951 | — | Jun 29, 2021 | |
| PALONOSETRON HYDROCHLORIDE | ACCORD HLTHCARE | ANDA 204615 | — | Mar 15, 2021 | |
| PALONOSETRON HYDROCHLORIDE | INGENUS PHARMS LLC | ANDA 208789 | — | May 22, 2020 | |
| PALONOSETRON HYDROCHLORIDE | EUGIA PHARMA | ANDA 204702 | AP | Nov 06, 2018 | |
| PALONOSETRON HYDROCHLORIDE | CHARTWELL RX | ANDA 209287 | AP | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE | CIPLA | ANDA 206396 | — | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 206801 | AP | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 206802 | AP | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE×2 | HOSPIRA | ANDA 207005 | AP | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE | MYLAN INSTITUTIONAL | ANDA 206416 | AP | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE×2 | QILU PHARM HAINAN | ANDA 205648 | — | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE | SAGENT PHARMS INC | ANDA 204289 | AP | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE | SAGENT PHARMS INC | ANDA 205870 | AP | Sep 19, 2018 | |
| PALONOSETRON HYDROCHLORIDE×2 | TEVA PHARMS USA | ANDA 090713 | — | Mar 23, 2018 | |
| PALONOSETRON HYDROCHLORIDE×2 | DR REDDYS | ANDA 201533 | — | Apr 21, 2016 | |
| PALONOSETRON HYDROCHLORIDE | SANDOZ | ANDA 202521 | AP | Oct 13, 2015 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Palonosetron hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
