FDA Orange Book · active-ingredient family
Penciclovir
Penciclovir is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DENAVIR · NDA 020629
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DENAVIRRLD | MYLAN | NDA 020629 | AB | Sep 24, 1996 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PENCICLOVIR | AMNEAL | ANDA 214100 | AB | Aug 22, 2025 | |
| PENCICLOVIR | PADAGIS ISRAEL | ANDA 212368 | AB | Sep 27, 2024 | |
| PENCICLOVIR | TORRENT | ANDA 216981 | BX | Aug 07, 2023 | |
| PENCICLOVIR | TEVA PHARMS USA | ANDA 212710 | AB | Nov 09, 2022 |
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.
Penciclovir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
