FDA Orange Book · active-ingredient family
Eplontersen sodium
Eplontersen sodium: 1 brand, 0 generics; first approved Dec 21, 2023; on patent until Apr 01, 2026.
On patent2 exclusivity periods
Generic status & protection
Protected until Apr 01, 2026 (earliest listed patent expiry).
Earliest patent expiry Apr 01, 2026Latest exclusivity ends Dec 21, 2030
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
4
Next patent expiry
Apr 01, 2026
3 mo ago
Originator applications
Brand (NDA) products
ASTRAZENECA ABNDA 21738820262 strengths
ASTRAZENECA ABNDA 21738820262 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | SOLUTION | SUBCUTANEOUS | Rx | — |
| EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | SOLUTION | SUBCUTANEOUS | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Dec 21, 2028
in 2 yr 6 mo
- ODE-461Orphan-drug exclusivity (7 years)
Dec 21, 2030
in 4 yr 6 mo
Orange Book patent file
Listed patents
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8101743 | Apr 01, 2026 | 3 mo ago | SubstanceProduct |
| 9127276 | May 01, 2034 | in 7 yr 11 mo | Substance |
| 9181549 | May 01, 2034 | in 7 yr 11 mo | Substance |
| 10683499 | Aug 25, 2034 | in 8 yr 3 mo | SubstanceProductU-2378 |
FDA approval span
Approval history
First approval
Dec 21, 2023
2 yr 7 mo ago
Most recent approval
Apr 15, 2026
3 mo ago
Approvals span 2023–2026 across 1 FDA application.
Brand (NDA) 1100%
Generic (ANDA) 00%
Eplontersen sodium — 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 BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
