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Last Updated: April 1, 2026

Drug Price Trends for NDC 70000-0309


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Best Wholesale Price for NDC 70000-0309

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
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

Market Analysis and Price Projections for NDC 70000-0309

Last updated: March 21, 2026

What is NDC 70000-0309?

The National Drug Code (NDC) 70000-0309 corresponds to Pirfenidone (Esbriet), used for idiopathic pulmonary fibrosis (IPF). It is marketed by Roche/Genentech.

Market Overview

The global IPF treatment market is driven by increasing diagnosis rates[1], aging populations, and lack of alternative therapies. Pirfenidone accounts for a significant share due to its approval and inclusion in treatment guidelines.

Market Size

  • Estimated global market value in 2022: $1.3 billion
  • Compound annual growth rate (CAGR) 2022–2028: 10%

Key Factors

  1. Growing IPF Incidence: IPF incidence ranges from 6.8 to 19.3 cases per 100,000 persons annually[2].
  2. Unmet Medical Need: Limited options restrict therapy to antifibrotic drugs like pirfenidone and nintedanib.
  3. Geographic Expansion: Approval in emerging markets increases potential patient pool.

Competitive Landscape

Product Market Share (2022) Price (per 270 mg capsule) Manufacturer
Pirfenidone (Esbriet) 65% $70-$80 Roche/Genentech
Nintedanib (Ofev) 35% $75-$85 Boehringer Ingelheim

Price Trends and Projections

Current Pricing

  • U.S.: Approximate wholesale price for a 270 mg capsule: $75
  • Europe: Variations between €50-€70 (~$55-$77)

Factors Influencing Price Stability

  • Market Competition: Nintedanib’s competitive pricing pressures.
  • Patent Status: Patent expiry is limited; patent cliff not until 2027.
  • Regulatory Changes: Price reimbursement policies in major markets affect net prices.

Price Projections (2023–2028)

Year Wholesale Price (per capsule) Key Drivers
2023 $75–$80 Stable patent protection, consistent demand
2024 $75–$80 Market saturation, new generic entries unlikely
2025 $70–$75 Potential patent expiry in select regions, slight downward pressure
2026 $65–$70 Increased generic competition, price negotiations
2027 $60–$65 First generics enter, significant price erosion expected
2028 $50–$60 Generics dominate, significant volume-based discounts

Volume and Revenue Forecasts

  • Estimated U.S. patient population: 20,000–25,000 treated annually[3].
  • Average annual dosing: 2.4 g/day, equating to approximately 2 capsules/day.
  • Projected revenue (2023): $120 million–$160 million in the U.S. alone, based on current pricing and distribution.

Regulatory and Patent Outlook

  • Patent expiry in the U.S.: 2027.
  • Patent expiry in Europe: 2025–2026.
  • Regulatory approvals in key markets: US (2014), EU (2016), Japan (2014).

Key Market Takeaways

  • The market for pirfenidone is growing steadily, driven by increasing IPF prevalence.
  • Pricing is expected to decline gradually with patent expirations and entry of generics.
  • Roche maintains market dominance through pricing strategies and ongoing clinical development.
  • Competitive pressures, especially from nintedanib, influence pricing and market share.
  • Future growth hinges on expanding indications and geographic penetration.

FAQs

  1. What are the main factors affecting pirfenidone pricing?
    Patent status, generic entry, competition from nintedanib, and reimbursement policies impact price levels.

  2. How does patent expiry influence future pricing?
    Patent expiry allows generics, which typically sell at 30-50% lower prices, to enter the market, causing significant price erosions.

  3. What markets are most lucrative for pirfenidone?
    The U.S., due to its large patient population and high willingness-to-pay, and Europe, with high prevalence and established reimbursement pathways.

  4. Are there ongoing clinical trials that could affect the market?
    Yes, trials exploring new indications or combination therapies may impact future demand.

  5. What is the expected timeframe for generic competition?
    In the U.S., patent expiration is projected for 2027, with generics potentially entering the market in 2028–2029.

References

[1] GlobalData. (2022). Pulmonary fibrosis market analysis.
[2] American Thoracic Society. (2017). IPF incidence and prevalence.
[3] IQVIA. (2023). U.S. pulmonary fibrosis drug utilization data.
[4] FDA. (2014). Drug approval history for pirfenidone.
[5] European Medicines Agency. (2016). Regulatory status of Esbriet.


Key Takeaways:

  • The global market is set to grow at a 10% CAGR, reaching over $2 billion by 2028.
  • Pricing will face downward pressure post-patent expiry, with generics expected from 2027 onward.
  • Roche’s dominant market position depends on patent protection and strategic pricing.
  • The market remains sensitive to legislative and reimbursement shifts.
  • Future growth opportunities include expanding indications and geographic penetration.

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