FDA Orange Book · active-ingredient family
Voriconazole
Voriconazole is approved as 4 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VFEND · NDA 021630
4
Brand (NDA)
28
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, powder, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VFENDRLD | PF PRISM CV | NDA 021630 | AB | Dec 19, 2003 | |
| VFENDRLD | PF PRISM CV | NDA 021267 | AP | May 24, 2002 | |
| VFENDRLD×2 | PF PRISM CV | NDA 021266 | AB | May 24, 2002 | |
| VORICONAZOLE | HIKMA | NDA 208562 | AP | Mar 09, 2017 |
Generic (ANDA) products (28)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VORICONAZOLE | ZHEJIANG NOVUS | ANDA 220078 | AP | May 05, 2026 | |
| VORICONAZOLE | HAINAN POLY PHARM | ANDA 220043 | — | Nov 14, 2025 | |
| VORICONAZOLE | HETERO LABS LTD V | ANDA 211598 | AB | Aug 08, 2025 | |
| VORICONAZOLE | ASPIRO | ANDA 218533 | AP | Apr 03, 2024 | |
| VORICONAZOLE | ZHEJIANG POLY PHARM | ANDA 216805 | AB | Jan 02, 2024 | |
| VORICONAZOLE | UBI | ANDA 211264 | AP | Mar 09, 2023 | |
| VORICONAZOLE | EUGIA PHARMA | ANDA 212162 | — | Feb 02, 2023 | |
| VORICONAZOLE | PHARMOBEDIENT | ANDA 210849 | — | Oct 11, 2022 | |
| VORICONAZOLE | MEITHEAL | ANDA 214516 | AP | May 09, 2022 | |
| VORICONAZOLE | GLAND | ANDA 211099 | AP | Mar 31, 2020 | |
| VORICONAZOLE | SLATE RUN PHARMA | ANDA 211661 | AP | Nov 30, 2018 | |
| VORICONAZOLE | ZYDUS PHARMS | ANDA 208983 | AP | Jul 16, 2018 | |
| VORICONAZOLE×2 | EPIC PHARMA LLC | ANDA 207049 | AB | Sep 07, 2016 | |
| VORICONAZOLE×2 | PRINSTON INC | ANDA 206654 | AB | Aug 08, 2016 | |
| VORICONAZOLE | NOVEL LABS INC | ANDA 206799 | AB | May 31, 2016 | |
| VORICONAZOLE×2 | AJANTA PHARMA LTD | ANDA 206181 | AB | May 24, 2016 | |
| VORICONAZOLE×2 | CADILA | ANDA 206747 | AB | May 24, 2016 | |
| VORICONAZOLE×2 | CHARTWELL RX | ANDA 207371 | AB | May 24, 2016 | |
| VORICONAZOLE×2 | RISING | ANDA 206762 | AB | May 24, 2016 | |
| VORICONAZOLE | AMNEAL PHARMS | ANDA 205034 | AB | Apr 13, 2016 | |
| VORICONAZOLE | ALMAJECT | ANDA 206398 | — | Mar 23, 2016 | |
| VORICONAZOLE×2 | AUROBINDO PHARMA LTD | ANDA 206837 | AB | Jan 22, 2016 | |
| VORICONAZOLE×2 | GLENMARK PHARMS LTD | ANDA 203503 | AB | Sep 02, 2015 | |
| VORICONAZOLE | RISING | ANDA 202361 | — | May 28, 2013 | |
| VORICONAZOLE | SANDOZ INC | ANDA 090862 | AP | May 30, 2012 | |
| VORICONAZOLE×2 | TEVA PHARMS | ANDA 091658 | — | Apr 06, 2012 | |
| VORICONAZOLE×2 | SANDOZ INC | ANDA 200265 | AB | Dec 12, 2011 | |
| VORICONAZOLE×2 | MYLAN PHARMS INC | ANDA 090547 | AB | Apr 22, 2010 |
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.
Voriconazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
