FDA Orange Book · active-ingredient family
Formoterol fumarate
Formoterol fumarate: 3 brands, 10 generics; first approved Feb 16, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
10
Listed patents
0
Presentations
13
Brand (NDA) products
Originator applications
- VIATRIS SPECIALTYNDA 0220072007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORADILRLDNOVARTISNDA 0208312001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.012MG/INH POWDER INHALATION Discontinued — - NOVARTISNDA 0215922006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.0085MG/INH POWDER INHALATION Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- FORMOTEROL FUMARATEDEVA HOLDING ASANDA 2183082025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATEDR REDDYSANDA 2159072025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATELEXENPHARMANDA 2164262024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATEMICRO LABSANDA 2183042024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATEMANKIND PHARMAANDA 2158832023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATEWILSHIRE PHARMS INCANDA 2156212022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATERITEDOSE CORPANDA 2164862022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATELUPINANDA 2150532022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATEALEMBICANDA 2150782021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN - FORMOTEROL FUMARATETEVA PHARMS USA INCANDA 0911412021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/2ML SOLUTION INHALATION Rx AN
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
26 yr ago
Most recent approval
1 yr 8 mo ago
Approvals span 2001–2025 across 13 FDA applications.
Brand (NDA) 323%
Generic (ANDA) 1077%
Formoterol fumarate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
