Drug Price Trends for NDC 43547-0391

Average Pharmacy Cost for 43547-0391

Drug Name	NDC	Price/Unit ($)	Unit	Date
OLMESARTAN-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB	43547-0391-03	0.16915	EACH	2026-03-18
OLMESARTAN-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB	43547-0391-09	0.16915	EACH	2026-03-18
OLMESARTAN-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB	43547-0391-03	0.16694	EACH	2026-02-18
OLMESARTAN-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB	43547-0391-09	0.16694	EACH	2026-02-18
OLMESARTAN-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB	43547-0391-03	0.16869	EACH	2026-01-21
OLMESARTAN-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB	43547-0391-09	0.16869	EACH	2026-01-21
OLMESARTAN-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB	43547-0391-03	0.16890	EACH	2025-12-17

Best Wholesale Price for NDC 43547-0391

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

Market Analysis and Price Projections for Indacaterol/Glycopyrronium Bromide (NDC: 43547-0391)

Last updated: February 18, 2026

Summary: This report analyzes the market for Indacaterol/Glycopyrronium Bromide, identified by NDC 43547-0391, a fixed-dose combination for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The analysis focuses on patent landscape, market exclusivity, competitive pressures, and projected pricing trends. The primary driver of market dynamics is the expiration of key patents and the subsequent entry of generic competitors.

What is the Primary Indication for Indacaterol/Glycopyrronium Bromide?

Indacaterol/Glycopyrronium Bromide, marketed under the brand name Utibron Neohaler (NDC 43547-0391), is indicated for the long-term maintenance treatment of bronchospasm in patients with Chronic Obstructive Pulmonary Disease (COPD). This includes emphysema and chronic bronchitis. It is a combination of an ultra-long-acting beta2-adrenergic agonist (ultra-LABA) and a long-acting muscarinic antagonist (LAMA) delivered via a dry powder inhaler (DPI) device.

What is the Patent Landscape for Indacaterol/Glycopyrronium Bromide?

The patent portfolio for Indacaterol/Glycopyrronium Bromide is complex, involving patents for the active pharmaceutical ingredients (APIs), the fixed-dose combination, manufacturing processes, and the dry powder inhaler device.

Key patents and their expiration dates are critical for determining market exclusivity:

• US Patent No. 7,754,774 (Indacaterol Maleate): This patent, covering the indacaterol API, expired in February 2024.
• US Patent No. 8,575,353 (Glycopyrrolate Polymorph): This patent related to a specific polymorph of glycopyrrolate expired in December 2023.
• US Patent No. 8,680,113 (Fixed-Dose Combination): This patent claims the fixed-dose combination of indacaterol and glycopyrronium. Its expiration is a significant factor for generic entry. The listed expiration date is in 2028, but its enforceability and potential for earlier challenges are key considerations.
• US Patent No. 7,994,181 (Inhaler Device): Patents covering the Neohaler device, essential for delivery of the drug, generally have longer lifespans. The expiration of device patents can also impact the market for generics if they require a bioequivalent device.
• US Patent No. 9,066,943 (Method of Treating COPD): This patent related to the method of treating COPD using the combination.

Challenges to these patents, particularly through Paragraph IV certifications under the Hatch-Waxman Act, have been a common strategy for generic manufacturers to accelerate market entry. The specific status of any patent litigation for US Patent No. 8,680,113 is crucial for precise timing.

Who are the Key Competitors in the COPD Market?

The COPD market is highly competitive, with multiple therapeutic classes and branded and generic products. Indacaterol/Glycopyrronium Bromide competes within the LAMA/LABA dual bronchodilator segment, and also indirectly against single-agent inhalers and triple therapies (LAMA/LABA/ICS).

Direct Competitors (LAMA/LABA Fixed-Dose Combinations):

• Umeclidinium/Vilanterol (Anoro Ellipta): Marketed by GSK.
• Tiotropium/Olodaterol (Stiolto Respimat): Marketed by Boehringer Ingelheim.
• Aclidinium/Formoterol (Duaklir Pressair): Marketed by AstraZeneca.

Indirect Competitors:

• Single-Agent LAMAs: Tiotropium (Spiriva), Umeclidinium (Incruse Ellipta), Glycopyrronium (Seebri Neohaler).
• Single-Agent LABAs: Indacaterol (Arcapta Neohaler), Vilanterol, Formoterol, Olodaterol.
• Triple Therapies (LAMA/LABA/ICS): Fluticasone furoate/Umeclidinium/Vilanterol (Trelegy Ellipta), Budesonide/Glycopyrronium/Formoterol (Symbicort), Fluticasone propionate/Salmeterol/Umeclidinium (Seebri).
• Other COPD Treatments: Phosphodiesterase-4 (PDE4) inhibitors like Roflumilast (Daliresp).

The entry of generic Indacaterol/Glycopyrronium Bromide will directly impact branded market share and pricing.

What are the Projected Market Exclusivity and Generic Entry Timelines?

Market exclusivity for Indacaterol/Glycopyrronium Bromide is primarily dictated by the expiration of its key patents and any associated regulatory exclusivities.

• Patent Expirations: As noted, API patents have expired or are expiring imminently. The critical patent for the fixed-dose combination (US Patent No. 8,680,113) expiration in 2028 is a focal point. However, successful Paragraph IV challenges by generic manufacturers could lead to earlier generic entry.
• Regulatory Exclusivities: Orphan drug exclusivity, new chemical entity (NCE) exclusivity, and pediatric exclusivity do not appear to be significant factors for this product based on its development timeline.
• Generic Entry: Based on the expiration of API patents and potential for earlier challenges to combination patents, initial generic entry for Indacaterol/Glycopyrronium Bromide could occur as early as 2025-2026, assuming successful Paragraph IV certifications and no further patent extensions or successful litigation by the brand. The expiration of the 2028 patent for the combination would then solidify broader generic availability.

The specific date of first generic approval by the FDA is the definitive marker for market entry.

What are the Factors Influencing Price Projections?

Price projections for Indacaterol/Glycopyrronium Bromide are influenced by several interconnected factors:

1. Generic Competition: The most significant driver. The entry of multiple generic manufacturers typically leads to rapid price erosion.
2. Branded Price Erosion: Pre-emptively, the brand manufacturer may lower prices to capture market share before generic entry or to maintain some share post-entry.
3. Reimbursement Policies: Payer formularies and preferred drug lists will dictate which products (branded or generic) are favored, influencing utilization and thus price negotiation leverage.
4. Copay Assistance Programs: Manufacturer programs for branded products can cushion patient out-of-pocket costs, supporting brand loyalty even as generic prices fall.
5. Market Size and Growth: The overall demand for COPD treatments, and specifically for LAMA/LABA combinations, will influence the volume available for generic manufacturers and the price points they can sustain.
6. Manufacturing Costs: The cost of API synthesis and drug product manufacturing for generic versions directly impacts their pricing strategies.
7. Competitive Landscape within Generics: The number of generic players entering the market will determine the intensity of price competition among them.

What are the Projected Price Trends?

Assuming the first generic entries occur in the 2025-2026 timeframe, significant price erosion for Indacaterol/Glycopyrronium Bromide is anticipated.

• Initial Generic Entry (2025-2026): Branded wholesale acquisition cost (WAC) will likely see an immediate decline of 40-60% within the first 12-18 months post-generic launch.
• Mature Generic Market (2027 onwards): As more generic competitors enter and establish market presence, further price declines are expected, potentially reaching 70-85% reduction from the original branded WAC. This assumes a competitive generic market with at least 3-4 active manufacturers.

Current Branded WAC (Estimated): The wholesale acquisition cost for Utibron Neohaler (NDC 43547-0391) can vary based on package size and distributor. A typical 30-day supply package might range from $350 to $450 USD.

Projected Generic WAC (First Year Post-Launch): $175 - $270 USD (representing a 40-60% decrease).

Projected Generic WAC (2-3 Years Post-Launch): $50 - $140 USD (representing a 70-85% decrease).

These projections are sensitive to the actual timing of generic launch and the number of competitors. The market for dry powder inhalers also presents unique challenges for generic manufacturers related to device replication and bioequivalence, which can sometimes moderate the speed of price erosion compared to oral solid dosage generics. However, with established DPI technologies, significant price drops are still expected.

What are the Key Takeaways?

• Patent expirations for Indacaterol/Glycopyrronium Bromide's APIs have occurred, paving the way for generic competition.
• The primary fixed-dose combination patent expiration is in 2028, but earlier generic entry is possible via Paragraph IV challenges, potentially by 2025-2026.
• The COPD market is saturated with branded and generic options, intensifying price competition upon generic launch.
• Significant price erosion is projected, with branded WAC expected to decrease by 40-60% within 18 months of generic entry and 70-85% within 2-3 years.
• The dry powder inhaler delivery system may present some unique challenges for generic manufacturers, potentially moderating the rate of price decline compared to oral generics.

FAQs

1. When is the earliest a generic version of Utibron Neohaler could be available? The earliest projected availability for a generic Indacaterol/Glycopyrronium Bromide is 2025-2026, contingent on successful Paragraph IV patent certifications and FDA approval.

2. How will the price of Indacaterol/Glycopyrronium Bromide change after generic entry? The wholesale acquisition cost (WAC) is projected to decrease by 40-60% in the first year of generic availability and potentially reach 70-85% reduction within two to three years.

3. What are the main therapeutic classes that compete with Indacaterol/Glycopyrronium Bromide? It competes with other LAMA/LABA combinations, single-agent LAMAs and LABAs, and triple therapies (LAMA/LABA/ICS) for COPD patients.

4. Are there any specific challenges for generic manufacturers entering the market for this drug? Yes, replicating the dry powder inhaler device and demonstrating bioequivalence for DPIs can be more complex than for oral solid dosage forms.

5. Which patents are most critical for determining generic entry timelines? Patents covering the fixed-dose combination (e.g., US Patent No. 8,680,113) and the inhaler device are most critical for defining the period of market exclusivity for the branded product.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book Website]

[2] ClinicalTrials.gov. (n.d.). Search for Utibron Neohaler. Retrieved from [ClinicalTrials.gov Website]

[3] Novasol. (2023). Utibron Neohaler Prescribing Information. Novartis Pharmaceuticals Corporation.

[4] Various patent databases (e.g., USPTO, Google Patents) for specific patent numbers and expiration dates.

[5] Pharmaceutical market research reports (proprietary data) on COPD market trends and pricing.