FDA Orange Book · active-ingredient family
Ferric carboxymaltose
Ferric carboxymaltose: 1 brand, 3 generics; first approved Jul 25, 2013; generic available.
Generic available4 exclusivity periods
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
6
Next patent expiry
Jan 08, 2027
in 5 mo
Brand (NDA) products
Originator applications
- AM REGENTNDA 20356520214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG IRON/15ML (50MG IRON/ML) SOLUTION INTRAVENOUS Rx AP 500MG IRON/10ML (50MG IRON/ML) SOLUTION INTRAVENOUS Rx — 1GM IRON/20ML (50MG IRON/ML) SOLUTION INTRAVENOUS Rx AP 100MG IRON/2ML (50MG IRON/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (3)
Abbreviated applications
- FERRIC CARBOXYMALTOSEMYLANANDA 2170762026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM IRON/20ML (50MG IRON/ML) SOLUTION INTRAVENOUS Rx AP - FERRIC CARBOXYMALTOSEMYLANANDA 2177692026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG IRON/2ML (50MG IRON/ML) SOLUTION INTRAVENOUS Rx AP - FERRIC CARBOXYMALTOSEMYLAN LABS LTDANDA 2125722026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG IRON/15ML (50MG IRON/ML) SOLUTION INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-915New indication exclusivity (3 years)
2 mo ago
- I-915New indication exclusivity (3 years)
2 mo ago
- I-915New indication exclusivity (3 years)
2 mo ago
- I-915New indication exclusivity (3 years)
2 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11478502 | in 5 mo | U-3472 | |
| 11433091 | in 5 mo | U-3435 | |
| 11364260 | in 5 mo | U-3637 | |
| 8895612 | in 5 mo | U-3115 | |
| 7612109 | in 6 mo | SubstanceProduct | |
| 7754702 | in 1 yr 7 mo | U-2555 |
Approval history
FDA approval span
First approval
13 yr 3 mo ago
Most recent approval
1 mo ago
Approvals span 2013–2026 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Ferric carboxymaltose: 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.
