dornase alfa (Pulmozyme)
dornase alfa is an FDA-licensed reference biologic from Genentech, Inc..
Reference product
Pulmozyme dornase alfa
Genentech, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for dornase alfa from the RCSB Protein Data Bank (PDB 4AWN).
Interactive biological assembly from PDB entry 4AWN. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.
Exclusivity & patent cliffs
Reference approval
Approval date of the reference dornase alfa product.
33 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
26 yr 1 mo ago
dornase alfa: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for dornase alfa.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
