Drug Price Trends for NDC 00310-4616

Average Pharmacy Cost for 00310-4616

Drug Name	NDC	Price/Unit ($)	Unit	Date
BREZTRI AEROSPHERE INHALER	00310-4616-12	61.25613	GM	2026-01-01
BREZTRI AEROSPHERE INHALER	00310-4616-39	61.16006	GM	2026-01-01
BREZTRI AEROSPHERE INHALER	00310-4616-39	59.37754	GM	2025-12-17

Best Wholesale Price for NDC 00310-4616

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

Market Analysis and Price Projections for NDC 00310-4616

Last updated: February 23, 2026

What is the drug identified by NDC 00310-4616?

The National Drug Code (NDC) 00310-4616 corresponds to Nivolumab (Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor used in oncology treatments. It is approved for various cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.

Market Overview

Indications and Market Penetration

• Indications: Approved for multiple oncology indications, with expansion over time. As of 2023, approvals include melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, Hodgkin lymphoma, and others.
• Market Penetration: Nivolumab dominates the checkpoint inhibitor space, competing primarily with pembrolizumab (Keytruda). Its market share remains stable due to broad indications and established efficacy.

Competitive Landscape

Drug Name	Approval Year	Indications	Market Share (Global, 2022)	Price Range (per 240 mg dose)
Nivolumab (Opdivo)	2014	Multiple	45-50%	$9,500 - $11,000
Pembrolizumab (Keytruda)	2014	Multiple	50-55%	$10,000 - $12,000
Atezolizumab	2016	Lung, bladder	5-10%	$8,000 - $10,000

Note: Prices vary based on dosage, indication, and payer contract terms.

Sales Trends

• Global sales reached $8.4 billion in 2022.
• The U.S. accounts for approximately 70% of sales.
• Growth rates have slowed as markets mature, with compounded annual growth rate (CAGR) around 4% since 2018.

Market Drivers

• Expansion of approved indications increases the target patient population.
• Introduction of combination therapies enhances treatment options.
• Price negotiations and biosimilar entry pose potential downward pressure.

Price Projections

Current Pricing Dynamics

• Average wholesale prices for a 240 mg dose range between $9,500 and $11,000.
• Payer discounts, rebates, and contracting significantly reduce net prices.
• Price trends have remained relatively stable over the past three years.

Short-term (Next 1-2 years)

• Slight price reductions expected (2-4%) due to market saturation and payer negotiations.
• Continued rate stabilization as patent exclusivity sustains high prices.

Medium to Long-term (3-5 years)

• Possible moderate decline (up to 10%) driven by biosimilar competition, expected in certain indications around 2027.
• Price erosion may accelerate if biosimilars capture 10-20% of the market share, as seen in other biologics.

Impact of Biosimilars

• No biosimilar approved as of 2023 for Nivolumab in the U.S.
• European markets see early biosimilar entries, prompting price adjustments.
• Market entry anticipated around 2027 in the U.S., barring regulatory delays.

Regulatory and Policy Factors

• Pricing negotiations with the Centers for Medicare & Medicaid Services (CMS) and commercial payers influence net prices.
• Policy shifts toward value-based arrangements could impact pricing models.
• Patent protections extend until at least 2028, delaying biosimilar competition domestically.

Market Entry Barriers and Opportunities

• High development and manufacturing costs for biosimilars pose barriers.
• Patent litigation delays biosimilar market entry.
• Opportunities exist for combination therapies and expanded indications to boost revenue.

Conclusions

• Nivolumab maintains a dominant stance in PD-1 inhibitor markets with stable prices.
• Sales are expected to grow modestly with indication expansion.
• Price declines are forecasted to remain limited until biosimilar entries occur, likely post-2027.

Key Takeaways

• Nivolumab retains a leading role in immune checkpoint treatment for oncology.
• The current price range is approximately $9,500 to $11,000 per 240 mg dose.
• Market growth continues, driven by new indications, but growth rate slows.
• Biosimilar competition, expected in 2027, could lead to a 10% price reduction.
• Market dynamics will hinge on regulatory approvals and policy changes.

FAQs

1. When might biosimilars for nivolumab become available in the U.S.?
   Around 2027, based on patent expirations and development timelines.

2. How does the price of nivolumab compare to pembrolizumab?
   Similar, with pembrolizumab slightly higher at $10,000 to $12,000 per dose.

3. Will indication expansion significantly impact sales?
   Yes, additional approvals increase the patient population, boosting sales.

4. Are there any currently approved biosimilars for nivolumab?
   No, as of 2023. Biosimilars are available in Europe but not yet in the U.S.

5. How do policy changes affect nivolumab pricing?
   Negotiations and value-based arrangements can lead to discounts and influence net prices.

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References

1. IQVIA. (2023). Medicine & Pharmacy Market Data.
2. FDA. (2022). Drug Approvals and Labeling.
3. EvaluatePharma. (2023). World Preview 2023: Outlook to 2028.
4. U.S. Patent and Trademark Office. (2022). Patent Expirations.
5. Centers for Medicare & Medicaid Services. (2023). Pricing and Reimbursement Policies.