Last updated: March 15, 2026
What Is NDC 49483-0692?
The National Drug Code (NDC) 49483-0692 corresponds to Ofev (nintedanib) 150 mg capsules. Ofev is an anti-fibrotic medication approved for idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and other fibrotic conditions. The drug is manufactured by Boehringer Ingelheim.
Market Overview
Indications and Patient Population
- IPF: Approximate prevalence of 20,000-30,000 patients in the U.S.
- SSc-ILD: Estimated 10,000-15,000 patients.
- Both indications primarily affect adults, with a higher prevalence among males and older populations.
Currently Approved Uses
- IPF (Since 2014)
- Systemic sclerosis-associated interstitial lung disease (SSc-ILD) (Since 2019)
Competitors
- Pirfenidone (Esbriet)
- Nintedanib (Ofev) holds a dominant position due to broader FDA approval and more extensive clinical data.
Market Size and Revenue
- In 2021, global sales exceeded $2 billion predominantly from IPF and SSc-ILD treatments.
- U.S. sales are estimated at $1.2 billion in 2022, with steady growth expected due to expanding indications and off-label use.
Pricing Landscape
| Drug |
Dosage |
Approximate Price per Capsule |
Approvals and Indications |
| Ofev (nintedanib) |
150 mg |
$320 - $350 |
IPF, SSc-ILD, other fibrotic lung diseases |
| Esbriet (pirfenidone) |
801 mg |
$290 - $320 |
IPF |
Prices are based on wholesale acquisition costs (WAC) and average wholesale prices (AWP) as reported by IQVIA in late 2022.
Price Trends and Projections
Historical Price Movements
- Since initial approval in 2014, Ofev's price per capsule has increased approximately 15-20% over the past five years.
- The price hike reflects inflation, manufacturing costs, and market exclusivity.
Price Drivers
- Regulatory approvals for additional indications can support price increases.
- Launch of biosimilars or generics could pressure prices downward.
- Negotiations with payers and insurance coverage influence net pricing and patient access.
Future Price Predictions (2023–2028)
| Year |
Expected Price per Capsule |
Comments |
| 2023 |
$340 - $360 |
Stable, minor increases expected due to inflation |
| 2024 |
$350 - $375 |
Anticipated due to potential label expansion or inflation |
| 2025 |
$355 - $385 |
Possible price stabilization or slight increase |
| 2026 |
$340 - $370 |
Market entry of biosimilars could exert downward pressure |
| 2027 |
$330 - $355 |
Extended patent protections might delay generic entries |
| 2028 |
$330 |
Likely stabilized, with no significant price hikes expected |
Key Factors Influencing Future Pricing
- Patent exclusivity expiring: 2028–2029 in the U.S.
- Biosimilar and generic entry: Starting around 2028, which could reduce prices by 15-30%.
- Regulatory changes or new indications may support price increases.
- Payer negotiations and pricing reforms could impact net prices.
Regulatory and Reimbursement Dynamics
- The drug is typically covered under Medicare Part D and commercial insurance plans.
- Negotiations with payers can impact patient co-pays and formularies.
- The push toward value-based pricing may lead to outcomes-based agreements.
Investment and Commercial Strategy Implications
- A high-value market with limited competition provides lucrative revenue streams.
- Price erosion expected with biosimilars within 3-4 years post-patent expiry.
- Expansion into new indications or geographic markets could buffer revenue declines.
- Cost management and payer relationships will be key during the patent cliff.
Conclusions
Nintedanib (NDC 49483-0692) maintains a high price due to limited competition and its broad indication profile. Price stability is projected through 2024, with moderate increases. The imminent introduction of biosimilars around 2028 is likely to exert downward pressure on prices.
Key Takeaways
- Nintedanib currently retails at approximately $340–$350 per capsule.
- Market size is driven by IPF and SSc-ILD, with a combined patient pool of under 50,000 in the U.S.
- Competition from biosimilars and generics could reduce prices by up to 30% post-patent expiry.
- Expansion of indications or approvals may support future price hikes.
- Reimbursement negotiations remain a critical component of net revenue potential.
FAQs
Q1: When will biosimilars likely enter the market for nintedanib?
A1: Biosimilars are expected to enter around 2028–2029, after patent expiration.
Q2: How does the price of NDC 49483-0692 compare to competitors?
A2: Its capsule price is roughly 10% higher than Esbriet, with similar efficacy profiles.
Q3: What are the main factors influencing future price increases?
A3: Regulatory approvals, label expansions, and market exclusivity prolongation.
Q4: How does payer coverage influence the net price?
A4: Negotiations and formulary placements can significantly reduce out-of-pocket costs and net revenue.
Q5: What regional differences affect pricing strategies?
A5: International markets display varied prices due to local regulations, reimbursement policies, and healthcare system structures.
References
- IQVIA. (2022). Pharmaceutical pricing and market access insights.
- U.S. Food and Drug Administration. (2019). Approval of nintedanib for systemic sclerosis-associated interstitial lung disease.
- EvaluatePharma. (2022). World preview of pharmaceutical sales.
- Boehringer Ingelheim. (2022). Ofev (nintedanib) prescribing information.
- FDA. (2020). Market exclusivity and biosimilar entry timelines.
