Purple Book reference family · 351(a) biologic
lonapegsomatropin-tcgd (Skytrofa)
lonapegsomatropin-tcgd is an FDA-licensed reference biologic from Ascendis Pharma Endocrinology Division A/S.
351(a) biologicBLA 761177 Ascendis Pharma Endocrinology Division A/S
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 761177
Skytrofa lonapegsomatropin-tcgd
Ascendis Pharma Endocrinology Division A/S
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference lonapegsomatropin-tcgd product.
1 yr ago
lonapegsomatropin-tcgd: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for lonapegsomatropin-tcgd.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
