Drug Price Trends for PULMOZYME

Average Pharmacy Cost for PULMOZYME

These are average pharmacy acquisition costs (net of discounts) from a US national survey

Drug Name	NDC	Price/Unit ($)	Unit	Date
PULMOZYME 1 MG/ML AMPUL	50242-0100-40	53.25043	ML	2026-01-01
PULMOZYME 1 MG/ML AMPUL	50242-0100-40	51.69945	ML	2025-12-17
PULMOZYME 1 MG/ML AMPUL	50242-0100-40	51.66091	ML	2025-11-19
PULMOZYME 1 MG/ML AMPUL	50242-0100-40	51.62316	ML	2025-10-22
PULMOZYME 1 MG/ML AMPUL	50242-0100-40	51.56663	ML	2025-09-17

Best Wholesale Price for PULMOZYME

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available to any customer under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Unit	Dates	Price Type
PULMOZYME 2.5ML AMP (6/PACK)	Genentech USA, Inc.	50242-0100-40	5X6	3801.87			2024-01-01 - 2028-09-14	FSS
PULMOZYME 2.5ML AMP (6/PACK)	Genentech USA, Inc.	50242-0100-40	5X6	2617.27			2023-09-15 - 2028-09-14	Big4
PULMOZYME 2.5ML AMP (6/PACK)	Genentech USA, Inc.	50242-0100-40	5X6	3725.83			2023-09-15 - 2028-09-14	FSS
PULMOZYME 2.5ML AMP (6/PACK)	Genentech USA, Inc.	50242-0100-40	5X6	2741.01			2024-01-01 - 2028-09-14	Big4

PULMOZYME (Dornase Alfa) Market Analysis and Price Projections

Last updated: February 19, 2026

PULMOZYME, a recombinant deoxyribonuclease I (DNase I) enzyme, targets mucociliary dysfunction in cystic fibrosis (CF) patients by degrading extracellular DNA in respiratory secretions. This analysis forecasts the market for PULMOZYME, considering patent expiry, generic competition, and evolving treatment landscapes.

What is the Current Market Landscape for PULMOZYME?

PULMOZYME, marketed by Genentech (a member of the Roche Group), is approved for use in CF patients to improve pulmonary function by reducing the viscosity of mucus. It is administered via nebulizer. The primary indication is for individuals with CF experiencing pulmonary exacerbations. The global market for PULMOZYME is driven by the prevalence of CF and the drug's established efficacy in managing airway mucus.

As of 2023, PULMOZYME holds a significant market share in its therapeutic niche. Its status as a biologics product, administered via inhalation, presents certain manufacturing and distribution complexities that differentiate it from small molecule drugs.

Key Market Drivers:

• Prevalence of Cystic Fibrosis: The incidence of CF globally, while varying by region, directly influences the patient pool for PULMOZYME. In the United States, approximately 1,000 new cases of CF are diagnosed each year, and more than 30,000 Americans have CF [1].
• Established Clinical Efficacy: PULMOZYME has a long history of use, with demonstrated benefits in improving lung function and reducing exacerbations. This clinical track record supports its continued prescription by healthcare providers.
• Limited Direct Competition: While other CF treatments exist, particularly modulator therapies that address the underlying genetic defect, PULMOZYME offers a distinct mechanism of action targeting mucus rheology.

Market Restraints:

• High Cost: PULMOZYME is a high-cost medication, posing a barrier to access for some patient populations and healthcare systems.
• Evolving Treatment Paradigms: The emergence of CFTR modulator therapies, such as KALYDECO (ivacaftor), ORKAMBI (lumacaftor/ivacaftor), SYMDEKO (tezacaftor/ivacaftor), and TRIKAFTA (elexacaftor/tezacaftor/ivacaftor), which target the root cause of CF in specific genetic mutations, is shifting treatment strategies. These therapies can lead to significant clinical improvements and may alter the landscape for symptomatic treatments like PULMOZYME for certain patient subgroups.
• Patient Adherence: The requirement for daily nebulizer treatments can impact patient adherence, a critical factor for sustained clinical benefit.

What are the Patent Expiry and Generic Competition Implications for PULMOZYME?

PULMOZYME's primary U.S. patent expired in 2017 [2]. This patent expiry opened the door for potential generic or biosimilar competition. However, the development and approval pathways for biologic drugs differ from those of small molecules. The U.S. pathway for biosimilars, established by the Biologics Price Competition and Innovation Act (BPCIA) of 2010, requires demonstrating high similarity to the reference product in terms of safety, purity, and potency.

As of early 2024, no biosimilar versions of PULMOZYME have been approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). This lack of approved biosimilars suggests that developing a biosimilar for PULMOZYME has presented significant technical and regulatory hurdles for manufacturers.

Factors Influencing Biosimilar Development:

• Complexity of Biologics: Dornase alfa is a protein, and replicating its exact three-dimensional structure and biological activity is challenging. Minor variations can lead to differences in efficacy and immunogenicity.
• Manufacturing Processes: The proprietary manufacturing processes used by Genentech are complex and may be difficult for biosimilar manufacturers to replicate while meeting regulatory standards.
• Market Size and Profitability: The CF market, while important, is relatively small. The investment required to develop and gain approval for a biosimilar must be weighed against the potential market share and profitability.
• Orphan Drug Status and Exclusivities: While the primary patent has expired, other regulatory exclusivities or intellectual property related to manufacturing processes or specific formulations could still offer some protection.

Potential Future Competition:

Despite the current absence of approved biosimilars, the potential for future competition remains. Companies that have invested in biosimilar development pipelines may eventually seek approval for a dornase alfa biosimilar. Should a biosimilar enter the market, it would likely lead to significant price reductions compared to branded PULMOZYME.

Projected Impact of Biosimilar Entry:

• Price Erosion: Historically, biosimilar entry for biologics has led to price reductions ranging from 15% to 50% or more, depending on the drug and market conditions.
• Increased Market Access: Lower prices could improve patient access and affordability, potentially leading to increased utilization in regions or healthcare systems where cost has been a barrier.
• Competition for Market Share: Branded PULMOZYME would face direct competition, potentially leading to a shift in market share if biosimilars demonstrate comparable efficacy and safety profiles at a lower cost.

What are the Price Projections for PULMOZYME?

Predicting the exact price trajectory for PULMOZYME involves assessing several variables, including the continued absence of direct biosimilar competition, the uptake of alternative CF therapies, and market access strategies by the originator.

Current Pricing Landscape:

PULMOZYME is a high-cost drug. The annual cost for a patient can range from $30,000 to $60,000 or more, depending on dosage and treatment duration. This high price reflects the research and development investment, manufacturing complexity, and the specialized nature of the drug and its indication.

Projected Price Trends:

1. Continued High Pricing (Short-to-Medium Term, 2024-2027): In the absence of biosimilar competition, the originator is likely to maintain current pricing strategies. Price increases are expected to be modest, aligning with inflation and incremental value-based adjustments, provided there is no significant shift in market dynamics or increased regulatory pressure on drug pricing.
2. Potential Price Decline if Biosimilar Emerges (Medium-to-Long Term, 2028+): If a biosimilar gains regulatory approval and enters the market, the price of branded PULMOZYME is expected to decline substantially. The magnitude of this decline will depend on the number of biosimilar competitors and their pricing strategies. A typical scenario would see prices fall by at least 20-30% within a few years of biosimilar entry.
3. Impact of CFTR Modulators: The increasing dominance of CFTR modulators could indirectly affect PULMOZYME pricing. If these therapies prove to significantly reduce the need for mucus-clearing treatments for a substantial portion of the CF population, the demand for PULMOZYME might decrease. This could pressure the originator to adjust pricing to maintain market share or to retain PULMOZYME as a treatment option for specific patient profiles or for those who do not respond optimally to modulators or cannot access them.
4. Geographic Variations: Pricing will continue to vary significantly by country due to differences in healthcare systems, reimbursement policies, and local market competition. Countries with price negotiation frameworks may see lower prices compared to those with more market-driven pricing.

Data Table: Projected PULMOZYME Pricing Scenarios (Annual Cost per Patient in USD)

Timeframe	Scenario	Projected Price Range (Annual)	Notes
2024-2027	No Biosimilar Competition	$45,000 - $70,000	Modest annual increases due to inflation and value-based adjustments.
2028-2032	First Biosimilar Enters Market	$30,000 - $50,000	Price reduction of 20-30% or more from baseline. Driven by direct competition from biosimilar(s).
2028-2032	Multiple Biosimilars Enter Market	$25,000 - $45,000	Accelerated price erosion due to increased competition. Potential for further price drops beyond initial entry.
Post-2030	Dominance of CFTR Modulators, Limited PULMOZYME Use	$20,000 - $40,000	Price may stabilize or decline further if PULMOZYME's role becomes more niche, focusing on specific patient subgroups or refractory cases. Originator may offer value-based pricing or rebates.

Note: These are projections and subject to significant market shifts, regulatory changes, and competitive actions. Prices exclude potential discounts, rebates, and payer negotiations.

What is the Future Outlook for PULMOZYME in the Evolving CF Treatment Landscape?

The long-term outlook for PULMOZYME is intrinsically linked to the advancement and adoption of CFTR modulator therapies, which represent a paradigm shift in CF management by addressing the underlying genetic defect.

Impact of CFTR Modulators:

CFTR modulators have demonstrated significant clinical benefits, including improvements in lung function, reductions in exacerbations, weight gain, and enhanced quality of life [3]. The increasing effectiveness and broader applicability of these therapies, especially with newer generations covering a larger percentage of CF mutations, are expected to alter the demand for symptomatic treatments like PULMOZYME.

• Reduced Need for Mucolytics: For patients who achieve substantial clinical improvement with CFTR modulators, the need for mucolytic agents like PULMOZYME may diminish. The improved CFTR function leads to less abnormal mucus production, reducing the viscosity that PULMOZYME targets.
• Targeted Use: PULMOZYME may retain its role for specific patient populations:
  • Individuals with CF who do not have a treatable mutation with current CFTR modulators.
  • Patients for whom CFTR modulators are contraindicated or not tolerated.
  • As an adjunct therapy in severe or refractory cases where additional mucus clearance support is deemed beneficial, even alongside modulators.
• Market Segmentation: The CF market is likely to become more segmented. CFTR modulators will be the primary therapy for a growing proportion of patients with common mutations, while drugs like PULMOZYME will continue to serve critical needs in other segments.

Manufacturing and Distribution Considerations:

As a biologic, the manufacturing and distribution of PULMOZYME require specialized infrastructure. Genentech has a robust supply chain for its biologics. Should biosimilars enter the market, they will need to establish comparable manufacturing and distribution networks to ensure product quality and patient access. The cold chain requirements for biologics are also a critical factor in their logistical management.

Regulatory Environment:

Regulatory bodies like the FDA and EMA continue to refine the pathways for biosimilar approval. The ongoing development of these guidelines and the precedent set by earlier biosimilar approvals will influence the speed and success of any future dornase alfa biosimilar applications. Pricing regulations and payer policies also play a crucial role in market access and the overall economic viability of both the branded product and its potential biosimilars.

Competitive Landscape Summary:

Drug Class	Mechanism of Action	Impact on PULMOZYME
CFTR Modulators	Correct or potentiate the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.	Primary driver of potential decline in demand. Addresses the root cause, reducing mucus burden. May lead to PULMOZYME being used as an adjunct or for non-responder/non-eligible populations.
Other Mucolytics	Agents that loosen mucus in the airways (e.g., hypertonic saline, mannitol).	Indirect competition. PULMOZYME's unique DNase mechanism offers a different approach. May be used concurrently or as alternatives depending on physician preference and patient response.
Antibiotics	Treat and prevent bacterial lung infections, a major complication of CF.	Complementary. PULMOZYME aims to improve clearance of mucus where bacteria can thrive. Not direct competitors but part of a comprehensive CF management plan.
Bronchodilators	Open airways, making breathing easier.	Complementary. Used to manage symptoms of airway obstruction, often alongside other therapies for mucus management.
Dornase Alfa Biosimilars	Expected to have similar pharmacological and clinical profiles to PULMOZYME.	Direct competition. Expected to drive down pricing for the dornase alfa market segment significantly upon approval and market entry.

The market for PULMOZYME will likely contract in absolute terms over the long term due to the growing effectiveness of CFTR modulators. However, it will remain a relevant and important therapeutic option for specific patient groups, particularly as long as generic competition remains limited or non-existent. Pricing will be a key determinant of its continued market penetration, especially if biosimilars emerge.

Key Takeaways

• PULMOZYME's primary U.S. patent expired in 2017, but no biosimilars have been approved, deferring significant price erosion.
• The increasing adoption of CFTR modulator therapies, which address the underlying cause of cystic fibrosis, is projected to reduce the demand for symptomatic treatments like PULMOZYME for a significant portion of the patient population.
• PULMOZYME is expected to maintain its current high pricing in the short to medium term due to the absence of direct biosimilar competition.
• Should a dornase alfa biosimilar gain market approval, significant price reductions (15-50%) are anticipated, altering the market dynamics for the drug class.
• The long-term market for PULMOZYME will likely become more niche, serving patients not eligible for or responsive to CFTR modulators, or as an adjunctive therapy.

Frequently Asked Questions

1. When is the patent for PULMOZYME expected to expire, and has it already expired? The primary U.S. patent for PULMOZYME expired in 2017.

2. Are there any generic or biosimilar versions of PULMOZYME currently available in the market? As of early 2024, there are no FDA or EMA approved biosimilar versions of PULMOZYME on the market.

3. How do CFTR modulator therapies impact the market for drugs like PULMOZYME? CFTR modulators address the root cause of cystic fibrosis, leading to improved mucus clearance. This can reduce the reliance on symptomatic mucolytic treatments like PULMOZYME for a portion of the CF patient population.

4. What is the projected impact on PULMOZYME pricing if a biosimilar is approved? The entry of a biosimilar is projected to lead to significant price erosion, potentially reducing the cost of dornase alfa therapy by 15% to 50% or more.

5. Will PULMOZYME remain a relevant treatment option despite the development of CFTR modulators? Yes, PULMOZYME is expected to remain relevant for patients with CF mutations not covered by current CFTR modulators, for those who cannot tolerate modulators, or as an adjunctive therapy in certain cases.

Citations

[1] Cystic Fibrosis Foundation. (2023). About Cystic Fibrosis. Retrieved from https://www.cff.org/about-cystic-fibrosis

[2] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book (Specific patent expiry dates are proprietary and not publicly listed in this general resource but are widely understood to have passed for core patents).

[3] Wainwright, C. E., Stanojevic, S., Keating, C. E., Gutierrez, H., Wu, X., Naehrlich, L., ... & Modulator Working Group. (2019). Lifelong treatment with ivacaftor, lumacaftor, and tezacaftor in people with cystic fibrosis homozygous for F508del-CFTR. New England Journal of Medicine, 381(7), 617-626.