dornase alfa (Pulmozyme)
dornase alfa is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1993
Reference approved
Reference product
Pulmozyme dornase alfa
Genentech, Inc.
- Approved
- Dec 30, 1993
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for dornase alfa, in chronological order.
Reference approval
Approval date of the reference dornase alfa product.
32 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
25 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for dornase alfa (Pulmozyme)?
No 351(k) biosimilars or interchangeable biosimilars referencing dornase alfa are listed in the FDA Purple Book yet.
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