FDA Orange Book · active-ingredient family
Artesunate
Artesunate: 1 brand, 0 generics; first approved May 26, 2020; on patent until Feb 16, 2044.
On patent1 exclusivity period
Generic status & protection
Protected until Feb 16, 2044 (earliest listed patent expiry).
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
2
Next patent expiry
Feb 16, 2044
in 17 yr 9 mo
Brand (NDA) products
Originator applications
- ARTESUNATERLDRSAMIVASNDA 2130362020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 110MG/VIAL POWDER INTRAVENOUS Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-290Orphan-drug exclusivity (7 years)
in 9 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12390442 | in 17 yr 9 mo | U-4433 | |
| 12121506 | in 17 yr 9 mo | Product |
Approval history
FDA approval span
First approval
6 yr 4 mo ago
Most recent approval
6 yr 4 mo ago
All 1 application were approved in 2020.
Brand (NDA) 1100%
Generic (ANDA) 00%
Artesunate: 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.
