asfotase alfa (Strensiq)
asfotase alfa is an FDA-licensed reference biologic from Alexion Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Strensiq asfotase alfa
Alexion Pharmaceuticals, Inc.
- Approved
- Oct 23, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for asfotase alfa, in chronological order.
Reference approval
Approval date of the reference asfotase alfa product.
10 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for asfotase alfa (Strensiq)?
No 351(k) biosimilars or interchangeable biosimilars referencing asfotase alfa are listed in the FDA Purple Book yet.
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