FDA Orange Book · active-ingredient family
Difelikefalin acetate
Difelikefalin acetate: 1 brand, 1 generic; first approved Aug 23, 2021; generic available.
Generic available1 exclusivity period
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
12
Next patent expiry
Nov 12, 2027
in 1 yr 2 mo
Brand (NDA) products
Originator applications
- VIFOR INTLNDA 2149162021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (1)
Abbreviated applications
- DIFELIKEFALIN ACETATEQILU PHARM HAINANANDA 2209192026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NCENew chemical entity exclusivity (5 years)
1 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10793596 | in 1 yr 2 mo | SubstanceProductU-3204 | |
| 10138270 | in 1 yr 2 mo | U-3204 | |
| 10017536 | in 1 yr 2 mo | SubstanceU-3204 | |
| 9359399 | in 1 yr 2 mo | U-3204 | |
| 9334305 | in 1 yr 2 mo | U-3204 | |
| 8536131 | in 1 yr 2 mo | SubstanceProductU-3204 | |
| 8486894 | in 1 yr 2 mo | U-3204 | |
| 8236766 | in 1 yr 2 mo | U-3204 | |
| 8217007 | in 1 yr 2 mo | U-3204 | |
| 7727963 | in 1 yr 2 mo | SubstanceProductU-3204 | |
| 7713937 | in 1 yr 2 mo | SubstanceProductU-3204 | |
| 7402564 | in 6 yr 3 mo | SubstanceProductU-3204 |
Approval history
FDA approval span
First approval
5 yr 2 mo ago
Most recent approval
22 d ago
Approvals span 2021–2026 across 2 FDA applications.
Brand (NDA) 150%
Generic (ANDA) 150%
Difelikefalin 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.
