FDA Orange Book · active-ingredient family
Rusfertide acetate
Rusfertide acetate: 1 brand, 0 generics; first approved Aug 28, 2026.
Brand only
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- TAKEDA PHARMS AMNDA 22060520265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 9.5MG BASE/VIAL POWDER SUBCUTANEOUS Rx — EQ 19MG BASE/VIAL POWDER SUBCUTANEOUS Rx — EQ 28MG BASE/VIAL POWDER SUBCUTANEOUS Rx — EQ 41MG BASE/VIAL POWDER SUBCUTANEOUS Rx — EQ 54MG BASE/VIAL POWDER SUBCUTANEOUS Rx —
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
25 d ago
Most recent approval
25 d ago
All 1 application were approved in 2026.
Brand (NDA) 1100%
Generic (ANDA) 00%
Rusfertide acetate: 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.
