FDA Purple Book · Reference family
drotrecogin alfa (Xigris)
drotrecogin alfa is an FDA-licensed reference biologic from Eli Lilly and Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2001
Reference approved
Reference product
351(a)BLA 125029
Xigris drotrecogin alfa
Eli Lilly and Company
- Approved
- Nov 21, 2001
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for drotrecogin alfa, in chronological order.
Reference approval
Approval date of the reference drotrecogin alfa product.
24 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for drotrecogin alfa (Xigris)?
No 351(k) biosimilars or interchangeable biosimilars referencing drotrecogin alfa are listed in the FDA Purple Book yet.
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