FDA Orange Book · active-ingredient family
Pentamidine isethionate
Pentamidine isethionate is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEBUPENT · NDA 019887
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEBUPENTRLD×2 | FRESENIUS KABI USA | NDA 019887 | AN | Jun 15, 1989 | |
| PENTAMRLD | FRESENIUS KABI USA | NDA 019264 | AP | Oct 16, 1984 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PENTAMIDINE ISETHIONATE | X-GEN PHARMS INC | ANDA 206983 | AN | Jan 20, 2023 | |
| PENTAMIDINE ISETHIONATE | PHARMOBEDIENT | ANDA 206982 | — | Mar 17, 2022 | |
| PENTAMIDINE ISETHIONATE | AVET LIFESCIENCES | ANDA 213806 | AP | Jan 07, 2021 | |
| PENTAMIDINE ISETHIONATE | PAI HOLDINGS | ANDA 206667 | AN | Apr 24, 2019 | |
| PENTAMIDINE ISETHIONATE | PAI HOLDINGS | ANDA 206666 | AP | Sep 28, 2017 | |
| PENTAMIDINE ISETHIONATE | BAXTER HLTHCARE | ANDA 073617 | — | Dec 18, 1995 | |
| PENTAMIDINE ISETHIONATE | WATSON LABS | ANDA 074303 | — | Aug 17, 1995 | |
| PENTACARINAT | ARMOUR PHARM | ANDA 073447 | — | Apr 28, 1994 | |
| PENTAMIDINE ISETHIONATE | HOSPIRA | ANDA 073479 | — | Jun 30, 1992 |
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.
Pentamidine isethionate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
