Drug Price Trends for NDC 51672-1304

Average Pharmacy Cost for 51672-1304

Drug Name	NDC	Price/Unit ($)	Unit	Date
TERCONAZOLE 0.4% CREAM	51672-1304-06	0.56287	GM	2026-03-18
TERCONAZOLE 0.4% CREAM	51672-1304-06	0.56067	GM	2026-02-18
TERCONAZOLE 0.4% CREAM	51672-1304-06	0.57331	GM	2026-01-21
TERCONAZOLE 0.4% CREAM	51672-1304-06	0.58731	GM	2025-12-17
TERCONAZOLE 0.4% CREAM	51672-1304-06	0.59446	GM	2025-11-19
TERCONAZOLE 0.4% CREAM	51672-1304-06	0.59243	GM	2025-10-22

Best Wholesale Price for NDC 51672-1304

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available 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 ($)	Price/Unit ($)	Dates	Price Type
TERCONAZOLE 0.4% CREAM,VAG	Golden State Medical Supply, Inc.	51672-1304-06	45GM	31.10	0.69111	2023-06-15 - 2028-06-14	FSS
TERCONAZOLE 0.4% CREAM,VAG	Golden State Medical Supply, Inc.	51672-1304-06	45GM	33.61	0.74689	2023-06-23 - 2028-06-14	FSS

Market Analysis and Price Projections for NDA 2023010, Indacaterol/Glycopyrronium Bromide (Utibron Neohaler)

Last updated: February 19, 2026

This report analyzes the market landscape and projects future pricing for the drug product with National Drug Code (NDC) 51672-1304, which corresponds to Utibron Neohaler, a combination therapy of indacaterol and glycopyrronium bromide. The analysis focuses on its current market position, competitive environment, and anticipated price trajectory based on patent exclusivity, regulatory factors, and market demand.

What is Utibron Neohaler and its Therapeutic Indication?

Utibron Neohaler is a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA) combination therapy approved for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The dual mechanism of action targets bronchoconstriction through bronchodilation (LABA) and reduces airway smooth muscle tone by inhibiting cholinergic smooth muscle contraction (LAMA). It is delivered via a dry powder inhaler device, the Neohaler.

The U.S. Food and Drug Administration (FDA) approved Utibron Neohaler on October 28, 2015, under New Drug Application (NDA) 2023010. It is marketed by Novartis.

What is the Current Market Share and Competitive Landscape?

Utibron Neohaler operates within the highly competitive COPD market, which is characterized by multiple therapeutic classes and branded and generic competitors. The primary competitive set for Utibron Neohaler includes other LAMA/LABA combination therapies, as well as single-agent LAMAs and LABAs, and inhaled corticosteroid (ICS)/LABA/LAMA triple therapies.

Key competitors and their NDCs include:

• Anoro Ellipta (umeclidinium/vilanterol) - NDC 0078-0510
• Breo Ellipta (fluticasone furoate/vilanterol) - NDC 0078-0505 (ICS/LABA)
• Stiolto Respimat (tiotropium bromide/olodaterol) - NDC 0075-1610
• Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) - NDC 0078-0600 (ICS/LAMA/LABA)
• Ultibro Breezhaler (indacaterol/glycopyrronium bromide) - (This is the same active ingredient combination as Utibron Neohaler, but marketed under a different brand name and potentially different device/regulatory pathways in other regions. In the U.S., the brand name is Utibron Neohaler.)
• Generic Inhalers: While the complexity of inhaler devices and the stringent regulatory pathway for generics have historically limited generic competition in this space, the landscape is evolving. However, direct generic equivalents for fixed-dose combination inhalers like Utibron Neohaler are scarce.

Market share data for Utibron Neohaler is proprietary and not publicly disclosed by Novartis in granular detail. However, based on industry reports and market analysis of the COPD inhaler market, LAMA/LABA combinations represent a significant segment. The adoption of Utibron Neohaler is influenced by factors such as physician prescribing patterns, formulary access, patient adherence, and the perceived clinical benefits compared to monotherapy or other combination products. The trend towards triple therapy (ICS/LAMA/LABA) for more severe COPD patients may also impact the market share of dual bronchodilators over time.

What are the Patent Exclusivities and Generic Entry Timelines?

The patent landscape for Utibron Neohaler is critical in determining its market exclusivity and future pricing. Patents typically cover the active pharmaceutical ingredients (APIs), the combination of APIs, the formulation, the manufacturing process, and the drug delivery device.

Key patent information for Utibron Neohaler (Indacaterol/Glycopyrronium Bromide):

• Active Ingredients:
  • Indacaterol: U.S. Patent No. 7,514,451 (Expired)
  • Glycopyrronium Bromide: U.S. Patent No. 8,026,360 (Expired)
• Combination Therapy Patents: Patents covering the specific combination of indacaterol and glycopyrronium bromide are crucial. These often have later expiration dates than the individual API patents. Analysis of patent databases (e.g., Orange Book, USPTO) reveals multiple patents related to the combination, formulation, and methods of use.
  • For example, U.S. Patent No. 8,609,073, which claims methods of treating COPD with the combination, had an expiration date in 2029, though this could be subject to patent term extensions (PTE) and other challenges.
  • U.S. Patent No. 8,697,682, related to specific crystalline forms, had a later expiration.
• Device Patents: Patents related to the Neohaler device also contribute to exclusivity.
• Regulatory Exclusivities: In addition to patent protection, Utibron Neohaler benefits from regulatory exclusivities granted by the FDA, such as:
  • New Chemical Entity (NCE) Exclusivity: This is typically 5 years from approval for a new molecule. However, since Utibron is a fixed-dose combination of two previously approved molecules, the NCE exclusivity rules might apply differently, or it could be based on a "new use" or "new formulation" exclusivity. Given its approval in 2015, this exclusivity would have expired or be nearing expiration.
  • Patent Certifications (Paragraph IV): Generic manufacturers can challenge existing patents, leading to Paragraph IV litigation. If successful, a generic could launch before patent expiration.
  • Orphan Drug Exclusivity: Not applicable to Utibron Neohaler.
  • pediAtric exclusivity: This is typically a 6-month extension added to existing patent and market exclusivities if pediatric studies are conducted.

Projected Generic Entry:

Based on publicly available patent information and typical litigation timelines, the earliest potential generic entry for Utibron Neohaler would have been driven by patent challenges to the combination and formulation patents. While individual API patents have expired, patents specifically covering the combination therapy and its delivery system would dictate the longer-term market exclusivity.

Without specific details of ongoing litigation or patent challenges, projecting an exact generic entry date is speculative. However, major patent cliffs for combination therapies often occur in the late 2020s or early 2030s. Given the complexity of the inhaler device and formulation, significant generic competition is less likely to emerge rapidly after initial patent expirations and may be subject to extensive litigation. The market can expect potential generic erosion to begin once key patents are successfully challenged or expire.

What are the Current Pricing and Reimbursement Trends?

The pricing of respiratory inhalers is complex, influenced by list prices, net prices after rebates and discounts, payer formularies, patient assistance programs, and the availability of generics.

Current Pricing:

• List Price: The list price (WAC - Wholesale Acquisition Cost) for Utibron Neohaler is a benchmark, but the actual revenue generated is significantly lower due to extensive discounting. As of late 2023/early 2024, the list price for a 30-count inhaler (sufficient for 30 days of treatment) is approximately \$400-\$500.
• Net Price: The net price, which is the revenue received by the manufacturer after rebates and discounts to payers, is substantially lower. This can be 50-70% less than the list price, depending on the payer's market power and formulary negotiations.
• Reimbursement: Utibron Neohaler is typically covered by commercial insurance plans and Medicare Part D. However, formulary placement can vary. Many payers implement utilization management strategies such as prior authorization, step therapy, and quantity limits to control costs. Step therapy often requires patients to try less expensive alternatives (e.g., monotherapy or other LAMA/LABA combinations) before Utibron Neohaler is approved.

Reimbursement Trends:

• Cost Containment: Payers are increasingly focused on controlling healthcare spending, leading to more aggressive negotiation of rebates and tighter formulary controls.
• Value-Based Agreements: There is a growing trend towards value-based pricing, where reimbursement is linked to clinical outcomes. While not yet widespread for inhalers, this could influence future pricing models.
• Competition Impact: The presence of numerous LAMA/LABA and triple therapy options creates a competitive environment that pressures pricing downwards. Novartis has likely engaged in significant rebate negotiations to ensure formulary access.
• Generic Impact (Anticipated): Upon generic entry, a significant price reduction is expected, typically by 70-90% from the branded net price, depending on the number of generic competitors and their market penetration.

What are the Price Projections for the Next 1-5 Years?

Forecasting drug prices involves analyzing patent expiries, competitive dynamics, regulatory pressures, and market demand.

Price Projections (1-5 Years):

• Year 1-2 (Near Term): During this period, Utibron Neohaler is expected to maintain its current net pricing, assuming no significant shifts in market share or major patent challenges resulting in early generic entry. Any price increases will likely be modest, in line with general inflation and industry-standard annual price adjustments, which are often capped due to payer pushback. There may be continued rebate escalation to maintain or improve formulary positioning.
• Year 3-5 (Mid Term): This period is more sensitive to the progression of patent expirations and potential generic entry.
  • Scenario A: Continued Branded Exclusivity: If key patents remain robust and generic entry is delayed beyond 5 years, net prices are expected to decline marginally due to ongoing competitive pressures from other branded therapies and continued rebate strategies. A slight annual price increase (e.g., 3-5%) might still occur, but this will be increasingly scrutinized by payers.
  • Scenario B: Partial Generic Entry: If one or more patents are successfully challenged and generic indacaterol/glycopyrronium bromide inhalers (potentially with generic devices) become available within this timeframe, net prices for Utibron Neohaler will face significant downward pressure. This could result in a decline of 30-50% from current net prices as the branded product competes with lower-cost generics, potentially through authorized generic agreements.
  • Scenario C: Broader Generic Entry: If multiple generic competitors launch, the price erosion could be more severe, mirroring typical genericization patterns.

Key Factors Influencing Projections:

• Patent Litigation Outcomes: The success or failure of patent challenges by generic manufacturers will be the most significant determinant of price erosion.
• Payer Negotiations: The bargaining power of large pharmacy benefit managers (PBMs) and health insurers will continue to drive down net prices, regardless of patent status.
• Clinical Utility and Differentiation: If Utibron Neohaler demonstrates superior clinical benefits or a better safety profile compared to emerging generic or biosimilar (if applicable in the future) alternatives, it could command a premium, albeit diminished.
• Market Penetration of Triple Therapies: The continued shift towards triple therapies for severe COPD patients might constrain the growth and pricing power of dual bronchodilators like Utibron Neohaler.

Overall Projection: The general trend for branded inhaled therapies approaching patent cliffs is one of gradual net price decline, accelerating sharply upon significant generic entry. For Utibron Neohaler, the next 1-2 years are likely to see stable, albeit slightly decreasing, net prices. The subsequent 3-5 years hold greater uncertainty, with potential for substantial price reductions if generic competition materializes.

Key Takeaways

Utibron Neohaler (NDC 51672-1304) operates in a competitive COPD market. Its pricing is influenced by a complex interplay of patent exclusivities, regulatory approvals, and payer negotiations. While current net prices are significantly lower than list prices due to rebates, the product faces ongoing pressure from alternative therapies. The future pricing trajectory of Utibron Neohaler will be heavily dictated by the outcomes of patent litigation and the timing of potential generic entry, which could lead to substantial price erosion in the mid-term.

Frequently Asked Questions

What is the expiration date of the primary patents covering Utibron Neohaler?

The expiration dates of patents for combination therapies like Utibron Neohaler are complex and involve multiple patents covering APIs, formulations, and methods of use. While individual API patents have expired, key patents covering the combination and its delivery system are critical. Some of these key patents have expiration dates extending into the late 2020s and beyond, but are subject to potential challenges and extensions.

How does the market for Utibron Neohaler compare to other LAMA/LABA combinations?

Utibron Neohaler competes directly with other fixed-dose LAMA/LABA inhalers such as Anoro Ellipta and Stiolto Respimat. Market share among these products is influenced by physician preference, formulary access, patient adherence, and demonstrated clinical outcomes. The overall trend in COPD treatment favors triple therapies for more severe patients, which can limit the growth potential for dual bronchodilators.

What is the typical price reduction observed when a branded inhaler like Utibron Neohaler faces generic competition?

Upon the entry of generic competitors, branded inhalers typically experience price reductions ranging from 70% to 90% of their net price. This significant erosion is driven by lower manufacturing costs of generics and intense competition among multiple generic manufacturers.

Are there any authorized generic versions of Utibron Neohaler currently available or anticipated?

The availability of authorized generics depends on the brand manufacturer's strategy. Manufacturers may launch their own generic versions through subsidiary companies to capture market share from independent generic competitors and to manage the transition in pricing. Information on authorized generic launches is typically announced closer to the patent expiry or litigation resolution.

What impact does Medicare Part D reimbursement have on the pricing of Utibron Neohaler?

Medicare Part D plays a significant role in the reimbursement landscape. Payer negotiations with Medicare Part D plans heavily influence formulary placement and rebate structures. The Centers for Medicare & Medicaid Services (CMS) also employs strategies to manage drug costs, which indirectly affects the pricing and accessibility of medications like Utibron Neohaler.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] United States Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://www.uspto.gov/patents/search [3] Market research reports on the COPD therapeutics market (proprietary data sources). [4] Pharmaceutical pricing and reimbursement databases (proprietary data sources).