LONAPEGSOMATROPIN-TCGD | B761177 | ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Aug. 25, 2021 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
kaleo, Inc. v. Ascendis Pharma Endocrinology, Inc. et al 2 patentssomatropin (growth hormone) | D. Del. | 2025-09-29 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.