BLARESPIRATORY (INHALATION)VIALPriority Review
Approved
Dec 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
Priority Review
PULMOZYME (dornase alfa) by Roche. Approved for recombinant human deoxyribonuclease 1 [epc]. First approved in 1993.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PULMOZYME (dornase alfa) is a recombinant human deoxyribonuclease 1 (DNase) administered via inhalation to break down extracellular DNA in respiratory secretions. It is used primarily in cystic fibrosis to improve lung function and reduce respiratory infections by clearing thick, viscous mucus from airways. The drug works by enzymatically degrading DNA present in sputum, thereby reducing mucus viscosity and improving clearance.
$0.002BPart D
LOE ApproachingApproaching loss of exclusivity with minimal Part D claims (415 in 2023) and modest spending ($2M), indicating a mature, niche product with limited team expansion opportunity.
Mechanism of Action
Pharmacologic Class:
Recombinant Human Deoxyribonuclease 1
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Pulmozyme in Cystic Fibrosis With Sinusitis
Started Jul 2013
0SinusitisCystic Fibrosis
A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
Started Dec 2012
99 enrolled
Cystic Fibrosis
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
Started May 2011
11 enrolled
Pulmonary Infections
A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis
Started Jun 2008
3 enrolled
Cystic Fibrosis
Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation Therapy + Chemotherapy
Started Feb 2008
36 enrolled
Head and Neck Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.