lonapegsomatropin-tcgd (Skytrofa)
lonapegsomatropin-tcgd is an FDA-licensed reference biologic from Ascendis Pharma Endocrinology Division A/S. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2025
Reference approved
Reference product
Skytrofa lonapegsomatropin-tcgd
Ascendis Pharma Endocrinology Division A/S
- Approved
- Jul 25, 2025
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for lonapegsomatropin-tcgd, in chronological order.
Reference approval
Approval date of the reference lonapegsomatropin-tcgd product.
10 mo ago
Frequently asked questions
Are there biosimilars approved for lonapegsomatropin-tcgd (Skytrofa)?
No 351(k) biosimilars or interchangeable biosimilars referencing lonapegsomatropin-tcgd are listed in the FDA Purple Book yet.
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