FDA Orange Book · active-ingredient family
Formoterol fumarate
Formoterol fumarate is approved as 3 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PERFOROMIST · NDA 022007
3
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PERFOROMISTRLD | VIATRIS SPECIALTY | NDA 022007 | AN | May 11, 2007 | |
| FORADILRLD | NOVARTIS | NDA 020831 | — | Feb 16, 2001 | |
| FORADIL CERTIHALER | NOVARTIS | NDA 021592 | — | Dec 15, 2006 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FORMOTEROL FUMARATE | DEVA HOLDING AS | ANDA 218308 | AN | Feb 11, 2025 | |
| FORMOTEROL FUMARATE | DR REDDYS | ANDA 215907 | AN | Jan 30, 2025 | |
| FORMOTEROL FUMARATE | LEXENPHARM | ANDA 216426 | AN | Oct 22, 2024 | |
| FORMOTEROL FUMARATE | MICRO LABS | ANDA 218304 | AN | Jun 26, 2024 | |
| FORMOTEROL FUMARATE | MANKIND PHARMA | ANDA 215883 | AN | Mar 22, 2023 | |
| FORMOTEROL FUMARATE | WILSHIRE PHARMS INC | ANDA 215621 | AN | Dec 13, 2022 | |
| FORMOTEROL FUMARATE | RITEDOSE CORP | ANDA 216486 | AN | Nov 25, 2022 | |
| FORMOTEROL FUMARATE | LUPIN | ANDA 215053 | AN | Aug 22, 2022 | |
| FORMOTEROL FUMARATE | ALEMBIC | ANDA 215078 | AN | Nov 22, 2021 | |
| FORMOTEROL FUMARATE | TEVA PHARMS USA INC | ANDA 091141 | AN | Jun 22, 2021 |
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.
Formoterol fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
