FDA Orange Book · active-ingredient family
Fomepizole
Fomepizole is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ANTIZOL · NDA 020696
1
Brand (NDA)
5
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANTIZOLRLD | PAR PHARM INC | NDA 020696 | — | Dec 04, 1997 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOMEPIZOLE | GLAND | ANDA 216791 | AP | Jul 06, 2023 | |
| FOMEPIZOLE | MYLAN INSTITUTIONAL | ANDA 079033 | — | Apr 07, 2009 | |
| FOMEPIZOLE | NAVINTA LLC | ANDA 078537 | AP | Mar 06, 2008 | |
| FOMEPIZOLE | MYLAN INSTITUTIONAL | ANDA 078639 | AP | Mar 03, 2008 | |
| FOMEPIZOLE | AM REGENT | ANDA 078368 | AP | Dec 14, 2007 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7553863 | Jun 30, 2027 | in 1 yr 1 mo | SubstanceProduct |
Fomepizole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
