FDA Purple Book · Reference family
somatropin (Accretropin)
somatropin is an FDA-licensed reference biologic from Emergent Biosolutions Canada Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2008
Reference approved
Reference product
351(a)BLA 021538
Accretropin somatropin
Emergent Biosolutions Canada Inc.
- Approved
- Jan 23, 2008
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for somatropin, in chronological order.
Reference approval
Approval date of the reference somatropin product.
18 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for somatropin (Accretropin)?
No 351(k) biosimilars or interchangeable biosimilars referencing somatropin are listed in the FDA Purple Book yet.
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