Last updated: February 28, 2026
What is NDC 60219-1677?
NDC 60219-1677 refers to Nintedanib (brand name OFEV), a tyrosine kinase inhibitor used for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. The drug was approved by the FDA in 2014 and is marketed by Boehringer Ingelheim.
Market Size and Key Drivers
Current Market Landscape
| Data Point |
Details |
| Indicated condition |
Idiopathic pulmonary fibrosis (IPF) |
| Global sales (2022) |
Approximately $1.2 billion (IQVIA) |
| US market share (2022) |
70% of global sales |
| Patients eligible in US |
~70,000 diagnosed with IPF (2021 CDC data) |
| Year-over-year growth (2020-2022) |
5-8% |
Market Growth Drivers
- Rising prevalence of IPF: Increase in diagnostic awareness and aging population.
- Expansion into other indications: Recent approvals for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
- Enhanced diagnosis rates: Improved screening protocols.
Competitive Landscape
| Competitor |
Indications |
Market Share (2022) |
Price Range (per 150 mg dose) |
Notes |
| Nintedanib (OFEV) |
IPF, SSc-ILD |
65% |
$6.50 - $8.00 |
Leading patent-protected drug |
| Pirfenidone (Esbriet) |
IPF |
25% |
$5.50 - $7.50 |
Alternative IPF therapy |
| Nintedanib generics |
IPF, SSc-ILD |
0% (pre-Patent expiry) |
Expected to reduce prices by 50-70% upon patent expiry |
Market entry anticipated within 2-3 years |
Patent Status and Implications
- The primary patent for OFEV expiring in 2027.
- Patent challenges and biosimilar or generic entries expected around 2028, reducing price competitiveness.
Price Projections
Near-Term (2023-2025)
- Prices will decline marginally due to inflation and payer negotiations.
- US retail price: Steady at around $6.50 to $8.00 per 150 mg capsule.
- Average wholesale price (AWP): Estimated at $7.20 per capsule.
Mid-Term (2026-2028)
- Patent expiration risks will lead to price erosion.
- Potential generic entry could reduce list prices by 50-70%.
- Expected price range post-generic entry: $3.00 to $4.00 per capsule.
Long-Term (Beyond 2028)
- Market penetration of biosimilars will decrease industry-wide prices.
- Pricing projections suggest a stabilized low of approximately $2.50 to $3.50 per capsule, assuming full generic market adoption.
Revenue Projections
| Year |
US Revenue (USD Millions) |
Global Revenue (USD Millions) |
Assumptions |
| 2023 |
840 (based on 70% US share) |
1,200 |
Flat pricing; moderate growth in global sales |
| 2024 |
882 |
1,284 |
5% volume increase; stable price |
| 2025 |
927 |
1,378 |
Price decline begins; volume continues growth |
| 2026 |
800 |
1,100 |
Patent expiry; price declines by 50% |
| 2027 |
600 |
900 |
Increased generic competition |
| 2028+ |
400 |
650 |
Full generic market; stabilized demand |
Price Control Trends & Policy Impact
- US: CMS and private payer negotiations influence net prices.
- EU: Price caps and reimbursement policies may further reduce prices.
- Global: Emerging markets will see lower prices due to procurement policies.
Key Takeaways
- The current market for Nintedanib (NDC 60219-1677) is approximately $1.2 billion globally.
- The patent protection extends to 2027, after which significant price reductions are anticipated.
- Entry of generics is expected within 2-3 years post-patent expiry, largely driven by biosimilar and generics manufacturers.
- Revenue is projected to decline gradually after 2026, with long-term pricing stabilized at approximately a third of current levels.
- The expanding indication portfolio and increasing diagnosis rates support sustained demand until patent expiry.
FAQs
Q1: When will patent expiration impact the pricing of Nintedanib?
A1: Patent expiry is expected in 2027, leading to potential generic entry in 2028.
Q2: How many patients are eligible for Nintedanib treatment in the US?
A2: Approximately 70,000 diagnosed IPF patients, with additional patients for other fibrotic indications.
Q3: What are the key competitors for Nintedanib?
A3: Pirfenidone (Esbriet), and potential biosimilars post-patent expiration.
Q4: How will pricing trends change after patent expiry?
A4: Prices could decrease by 50-70%, potentially stabilizing around $3.00 per capsule.
Q5: What factors influence the market beyond patent expiration?
A5: New indications, diagnostic rates, payer negotiations, and biosimilar adoption.
References
- IQVIA. (2022). Global pharmaceutical sales data.
- CDC. (2021). Prevalence of idiopathic pulmonary fibrosis.
- US Food and Drug Administration. (2014). Approval of Nintedanib for IPF.
- Boehringer Ingelheim. (2023). Product information and market data.
- FDA. (2022). Patent and exclusivity data for Nintedanib.
