Last updated: February 20, 2026
What is the drug associated with NDC 43598-0765?
NDC 43598-0765 corresponds to Ofev (nintedanib) 150 mg capsules. Ofev is an anti-fibrotic agent approved for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.
Market Overview
The global market for anti-fibrotic agents, primarily driven by IPF treatment, is expanding. Ofev holds approximately 75-80% of the market share in IPF therapeutics, with other competitors such as Esbriet (pirfenidone).
Market Size
- Global IPF drug market value (2022): Estimated at USD 950 million.
- Growth rate: Compound Annual Growth Rate (CAGR) of approximately 10% through 2027.
Competitive Landscape
| Drug |
Market Share |
Indications |
Pricing (per 150 mg capsule) |
Launch Year |
| Ofev (nintedanib) |
75-80% |
IPF, systemic sclerosis-associated ILD |
~$200 |
2014 |
| Esbriet (pirfenidone) |
20-25% |
IPF |
~$90 |
2011 |
Key factors influencing market dynamics:
- Increased diagnosis of IPF.
- Expansion into systemic sclerosis-associated ILD.
- Off-label use in other fibrotic diseases.
Price Trend Analysis
Historical Price Trends (USD per capsule)
| Year |
Price (USD) |
Notes |
| 2014 |
~$200 |
Market entry for Ofev |
| 2018 |
~$210 |
Slight increase; inflation adjustment |
| 2022 |
~$200 |
Price stabilization |
| 2023 |
~$200 |
No significant change |
Current Pricing Structure
The average wholesale price (AWP) remains stable at approximately $200 per capsule (~$30,000 annually for a standard 150 mg dosage daily). Managed care discounts and pharmacy benefit manager (PBM) negotiations can reduce the net price.
Potential Price Drivers and Constraints
- Patent protection expiration anticipated in 2029; patent cliff could pressure prices.
- Introduction of generics post-2029 likely to halve current prices.
- Regulatory pressures and payor push for price controls could influence future pricing.
- Market expansion into additional fibrotic indications could sustain higher pricing levels temporarily.
Projections (2024-2028)
| Year |
Projected Domestic Price (USD per capsule) |
Expected Market Penetration |
Remarks |
| 2024 |
$200 |
80% |
Stable, barring new competition |
| 2025 |
$200-$210 |
85% |
Slight price increase possible |
| 2026 |
$200-$210 |
85% |
Market stabilization |
| 2027 |
$180-$200 (post-patent expiry) |
75%-80% |
Competition from generics emerges |
| 2028 |
$150-$180 (post-patent expiry) |
70%-75% |
Price erosion accelerates |
Note: This projection assumes no significant regulatory changes or market disruptors.
Implications for Stakeholders
- Pharmaceutical companies: Patent expiry in 2029 presents a commercial risk. Planning for generic competition is essential.
- Payers and providers: Anticipate potential price reductions after patent expiry; sustained use depends on clinical efficacy and cost-effectiveness.
- Investors: Current valuations reflect high market share. Long-term value hinges on post-patent market dynamics.
Key Takeaways
- NDC 43598-0765 (Ofev) commands stable pricing at approximately $200 per capsule.
- The market is expected to grow at a CAGR of 8-10%, driven by increased diagnosis and expanded indications.
- Price pressure from patent expiration in 2029 will likely lead to significant declines post-2028.
- Competition from generics will erode market share and prices, affecting revenue streams.
- Strategic positioning before patent expiry is crucial for maximizing market value.
FAQs
1. When does patent protection for Ofev expire?
Patent protection is expected to expire in 2029; patent extensions or new formulations could modify this timeline.
2. What factors could accelerate price declines?
Entry of generics, regulatory changes, new competing drugs, or government-led price controls.
3. Are there approved biosimilars or generics yet?
As of 2023, no biosimilars or generics are approved; patent expiry will enable market entry post-2029.
4. How do insurance negotiations impact net pricing?
Managed care discounts and rebate structures typically reduce the wholesale list price by 20-40%.
5. What are the growth prospects beyond 2028?
Market expansion into new indications, including fibrotic diseases beyond IPF, will influence long-term demand.
References
- MarketWatch. (2022). Global IPF drug market size and forecast. Retrieved from [URL]
- IQVIA. (2023). US prescription drug market data. Retrieved from [URL]
- FDA. (2021). Approval history for Ofev (nintedanib). Retrieved from [URL]
- EvaluatePharma. (2022). Price trends and patent expiry analysis. Retrieved from [URL]
- Statista. (2023). Analysis of generic drug entry post-patent expiration. Retrieved from [URL]
Note: URLs omitted for brevity.
