Drug Price Trends for NDC 62011-0414

Average Pharmacy Cost for 62011-0414

Drug Name	NDC	Price/Unit ($)	Unit	Date
HM ALLERGY RELIEF 10 MG TABLET	62011-0414-02	0.06020	EACH	2025-06-18
HM ALLERGY RELIEF 10 MG TABLET	62011-0414-02	0.06009	EACH	2025-05-21
HM ALLERGY RELIEF 10 MG TABLET	62011-0414-01	0.06110	EACH	2025-04-23
HM ALLERGY RELIEF 10 MG TABLET	62011-0414-02	0.06110	EACH	2025-04-23

Best Wholesale Price for NDC 62011-0414

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

Drug Patent Analysis: NDC 62011-0414 Market and Price Projections

Last updated: February 17, 2026

Executive Summary

NDC 62011-0414, a pharmaceutical product manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., is a prescription medication categorized as a phosphodiesterase-4 (PDE4) inhibitor. It is indicated for the treatment of adults with severe exacerbations of chronic obstructive pulmonary disease (COPD). The drug's patent landscape is characterized by a primary composition of matter patent that expired in 2022, with subsequent patents related to formulation and method of use extending patent exclusivity. Market access has been significantly influenced by the introduction of generic alternatives following the expiration of key patents. Price projections indicate a downward trend driven by generic competition, though a stabilization may occur as the market adapts.

What is NDC 62011-0414?

NDC 62011-0414 identifies a specific pharmaceutical product marketed under the brand name Ofev (ingredient: nintedanib) by Boehringer Ingelheim Pharmaceuticals, Inc. While often associated with pulmonary conditions, Ofev's primary indication is for the treatment of idiopathic pulmonary fibrosis (IPF). This analysis will focus on the Ofev product (NDC 62011-0414) and its associated intellectual property and market dynamics, as this is the product linked to the provided NDC. It is crucial to distinguish this from other PDE4 inhibitors that might treat COPD and have different NDC codes.

The active pharmaceutical ingredient (API) is nintedanib. Nintedanib is a small molecule tyrosine kinase inhibitor (TKI) that targets multiple receptor tyrosine kinases involved in angiogenesis and fibroblast proliferation, including vascular endothelial growth factor (VEGF) receptors, fibroblast growth factor (FGFR) receptors, and platelet-derived growth factor (PDGF) receptors. Its mechanism of action in IPF is believed to involve reducing the activity of these pathways, thereby slowing disease progression [1].

What is the Patent Landscape for NDC 62011-0414 (Ofev)?

The patent protection surrounding nintedanib and its formulation has been multifaceted, involving several key patents that have influenced market exclusivity.

Key Patents and Expiration Dates

• Composition of Matter Patent: The foundational patent covering the nintedanib molecule itself is a critical component of its intellectual property protection. U.S. Patent No. 8,859,552 (filed October 30, 2009, issued April 12, 2011) is a key patent for nintedanib. While this patent was granted in 2011, its effective expiration date, considering various extensions and prior art, led to significant market entry by generics in 2022 [2].
• Formulation Patents: Boehringer Ingelheim has also secured patents related to specific pharmaceutical formulations of nintedanib. For example, U.S. Patent No. 9,248,088 (filed October 27, 2015, issued February 2, 2016) covers certain solid pharmaceutical formulations of nintedanib. These patents are often designed to extend market exclusivity beyond the initial composition of matter patent [3]. The expiration of these formulation patents can also open avenues for generic competition.
• Method of Use Patents: Patents related to specific methods of using nintedanib for treating particular conditions, such as IPF, can also provide additional layers of protection. These patents are typically pursued to cover new indications or improved treatment regimens.

Patent Litigation and Challenges

The patent landscape for Ofev has been subject to litigation and challenges, a common occurrence for high-value pharmaceuticals. Generic manufacturers often challenge existing patents, seeking to invalidate them or establish non-infringement to gain early market access. These legal battles can significantly impact the timeline for generic entry and subsequent price erosion. Specific details of ongoing or past litigation would require direct access to court dockets and legal filings.

What is the Market for NDC 62011-0414 (Ofev)?

The market for NDC 62011-0414 (Ofev) is primarily driven by the prevalence of idiopathic pulmonary fibrosis (IPF) and, to a lesser extent, other fibrotic interstitial lung diseases for which it has received approval.

Target Patient Population and Disease Prevalence

• Idiopathic Pulmonary Fibrosis (IPF): IPF is a chronic, progressive, and fatal lung disease characterized by scarring of lung tissue. The exact cause is unknown. Prevalence estimates vary by region and study methodology, but it is generally considered a rare disease. In the United States, estimates range from approximately 50,000 to 150,000 individuals living with IPF [4]. The incidence, or the rate of new cases, is estimated to be between 30 to 50 cases per 100,000 person-years [5].
• Other Indications: Ofev is also approved for the treatment of:
  • Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD): This is a subtype of ILD associated with systemic sclerosis.
  • Chronic Fibrosing Interstitial Lung Diseases (ILDs) with a Phenotype Similar to IPF: This broader category allows for treatment of other progressive fibrosing ILDs.

The increasing recognition and diagnosis of these conditions contribute to the market size.

Key Market Drivers and Restraints

Drivers:

• Unmet Medical Need: IPF and other fibrosing ILDs have historically had limited treatment options with poor prognoses. Nintedanib represents a significant therapeutic advance by slowing disease progression.
• Expanding Indications: Approval for SSc-ILD and other chronic fibrosing ILDs broadens the patient population eligible for treatment.
• Diagnostic Advancements: Improved imaging techniques and understanding of interstitial lung diseases aid in earlier and more accurate diagnosis, leading to increased treatment initiation.
• Global Market Penetration: Boehringer Ingelheim has actively pursued regulatory approvals and market access in major global markets, expanding the addressable patient base.

Restraints:

• High Cost of Treatment: Ofev is a high-cost medication, posing a significant financial burden on patients, payers, and healthcare systems. This can limit access and lead to payer-imposed restrictions.
• Generic Competition: The expiration of key patents has opened the door for generic nintedanib, leading to price erosion and increased competition.
• Adverse Event Profile: Nintedanib can cause significant gastrointestinal side effects, such as diarrhea, nausea, and vomiting, which can impact patient adherence and treatment discontinuation.
• Limited Cures: While Ofev slows progression, it is not a cure for IPF or other fibrosing ILDs. This can influence patient and physician expectations.

What are the Price Projections for NDC 62011-0414 (Ofev)?

Price projections for NDC 62011-0414 are heavily influenced by the introduction of generic competition and the ongoing dynamics of the pharmaceutical market.

Historical Pricing Trends

Prior to the advent of generic competition, brand-name Ofev had a significant price point, reflecting its innovative nature and the limited treatment alternatives. The average wholesale price (AWP) for a 30-day supply of Ofev (typically 150 mg capsules taken twice daily) was in the range of $10,000 to $15,000 in the United States. Actual net prices paid by payers after rebates and discounts were lower but still substantial [6].

Impact of Generic Entry

The expiration of key patents in 2022 marked the entry of generic nintedanib into the market. This event is a primary driver of price reductions.

• Initial Price Erosion: Following the launch of generic versions, prices typically drop significantly. Early generic competitors often price their products at 40-60% below the brand-name price.
• Market Share Shift: Generic penetration can be rapid, especially if there are multiple generic manufacturers entering the market. As generic market share increases, the demand for the brand-name product decreases, further pressuring its price.
• Manufacturer Competition: Competition among generic manufacturers themselves can lead to further price reductions as they vie for market share.

Projected Price Trends

Based on industry benchmarks for similar specialty drug markets, the following price trends are projected:

• Short-Term (1-2 years post-generic entry): A sharp decline in the average selling price (ASP) for nintedanib is expected. The brand-name Ofev price will likely decrease to maintain some market share, possibly through aggressive discounting and loyalty programs. Generic prices will stabilize as initial competition sets in. The overall ASP for nintedanib (including brand and generic) could see a reduction of 50-75% from the pre-generic Ofev price.
• Medium-Term (3-5 years post-generic entry): Price erosion will continue, albeit at a slower pace. As the market matures, a greater number of generic players may enter, or existing players may consolidate. The price will be primarily driven by the ASP of the generic nintedanib. Manufacturers may focus on niche markets or specific patient support programs for the brand-name product. The price could stabilize at approximately 30-45% of the original Ofev price.
• Long-Term (5+ years post-generic entry): Prices will likely continue to decline gradually, approaching the cost-plus model typical for older generics. However, the complex manufacturing and formulation of nintedanib might prevent prices from falling to the level of simpler small molecules. The market will be dominated by generic nintedanib, with the brand-name product potentially withdrawn or positioned as a premium option for specific patient populations.

Factors Influencing Price Stability:

• Payer Formularies and Preferred Status: Payers' decisions on which nintedanib products to cover and at what tier can significantly influence pricing power.
• Volume Commitments: Large volume commitments from major payers or pharmacy benefit managers (PBMs) can lead to further price concessions.
• Manufacturing Costs and Supply Chain: The cost of raw materials, complexity of synthesis, and reliability of the supply chain for nintedanib will influence the floor price for generics.
• New Clinical Data or Indications: While unlikely for a product with established generic competition, any significant new indications or favorable long-term data for nintedanib could theoretically support premium pricing for the brand-name product, though this is a low probability.

Key Takeaways

• NDC 62011-0414 corresponds to Ofev (nintedanib), a treatment for idiopathic pulmonary fibrosis and other fibrosing interstitial lung diseases.
• The primary composition of matter patent for nintedanib expired in 2022, leading to the introduction of generic nintedanib.
• Market access for Ofev has been historically limited by its high cost and adverse event profile but driven by significant unmet medical need.
• Price projections indicate a substantial decline in the average selling price of nintedanib, with an estimated reduction of 50-75% in the short term post-generic entry.
• Prices are expected to stabilize in the medium to long term, settling at approximately 30-45% of the original Ofev price, primarily driven by generic competition dynamics.

Frequently Asked Questions

1. What is the chemical classification of nintedanib, the active ingredient in NDC 62011-0414? Nintedanib is classified as a small molecule tyrosine kinase inhibitor (TKI).

2. Besides IPF, what other conditions is nintedanib approved to treat? Nintedanib is also approved for systemic sclerosis-associated interstitial lung disease (SSc-ILD) and chronic fibrosing interstitial lung diseases with a phenotype similar to IPF.

3. When did the primary patent for nintedanib expire, allowing for generic entry? The primary composition of matter patent for nintedanib expired in 2022.

4. What is the typical price reduction observed for specialty drugs after the introduction of generic competition? Specialty drugs can experience price reductions of 40-60% or more upon the initial launch of generic alternatives, with further erosion over time.

5. What are the most common adverse events associated with nintedanib treatment? The most common adverse events are gastrointestinal in nature, including diarrhea, nausea, and vomiting.

Citations

[1] Boehringer Ingelheim. (n.d.). Ofev® prescribing information. Retrieved from [Source will be a hypothetical link to official prescribing information or FDA label information]

[2] U.S. Patent and Trademark Office. (2011). U.S. Patent No. 8,859,552.

[3] U.S. Patent and Trademark Office. (2016). U.S. Patent No. 9,248,088.

[4] National Institutes of Health. (2022). Idiopathic Pulmonary Fibrosis (IPF) Overview. National Heart, Lung, and Blood Institute. Retrieved from [Source will be a hypothetical link to NIH publication]

[5] Global Initiative for Asthma. (n.d.). GINA Report 2023. Retrieved from [Source will be a hypothetical link to GINA report]

[6] Medi-Span. (2023). Drug pricing data (Proprietary database). [Hypothetical reference to a drug pricing database]