TIVIDENOFUSP ALFA-EKNM | B761485 | DENALI THERAPEUTICS INC.
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Mar. 24, 2026 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment | Mar. 24, 2033 | Open now(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Marketing-entry ceiling (litigation risk)
No listed or discovered patents.
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
No patent or exclusivity listings for this strength.