FDA Orange Book · active-ingredient family
Florquinitau f-18
Florquinitau f-18: 1 brand, 0 generics; first approved Aug 13, 2026; on patent until Jun 09, 2035.
On patent1 exclusivity period
Generic status & protection
Protected until Jun 09, 2035 (earliest listed patent expiry).
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
2
Next patent expiry
Jun 09, 2035
in 8 yr 10 mo
Brand (NDA) products
Originator applications
- CERVEAU LANTHEUSNDA 2204962026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1-40mCi/ML SOLUTION INTRAVENOUS Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NCENew chemical entity exclusivity (5 years)
in 5 yr
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9808542 | in 8 yr 10 mo | SubstanceProductU-4597 | |
| 10022461 | in 8 yr 10 mo | U-4597 |
Approval history
FDA approval span
First approval
1 mo ago
Most recent approval
1 mo ago
All 1 application were approved in 2026.
Brand (NDA) 1100%
Generic (ANDA) 00%
Florquinitau f-18: 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
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