Last updated: March 1, 2026
What Is NDC 50228-0460?
NDC 50228-0460 corresponds to Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor used primarily for type 2 diabetes management. It is also approved for heart failure and chronic kidney disease in specific populations.
Market Overview
Therapeutic Class and Approved Indications
- Therapeutic Class: SGLT2 inhibitor
- Indications:
- Type 2 diabetes mellitus (T2DM)
- Heart failure with reduced ejection fraction (HFrEF)
- Chronic kidney disease (CKD)
Market Size
- Global Diabetes Market: Estimated at USD 89 billion in 2022; expected CAGR of 7% through 2030 [1].
- SGLT2 Inhibitor Market: USD 19 billion in 2022; projected to reach USD 40 billion by 2030, driven by new indications [2].
- Farxiga's Share: Approximate 25% of the SGLT2 inhibitor market, with sales exceeding USD 4.7 billion in 2022 [3].
Competitive Landscape
Regulatory Updates
- Expanded indications: The FDA approved Farxiga for HFrEF in patients with and without diabetes in 2021.
- Label updates: As of 2023, the label includes use for CKD regardless of diabetes status.
Price Projections
Current Pricing
- List Price: Approximately USD 600–700 per month for the branded drug in the US.
- Average Selling Price (ASP): USD 580 per month, factoring in discounts and rebates [4].
- Reimbursement Trends: Payors increasingly favor utilization due to cost-saving benefits in heart failure and CKD.
Future Price Trends
-
Market Competition Effect:
- As biosimilars or generics enter the market, prices could decline by 20–40% over 3–5 years.
-
Indication Expansion:
- Broader use in CKD and heart failure may sustain or increase prices due to higher perceived value.
-
Reimbursement Policies:
- Growing adoption in value-based payment models could moderate increases but favor volume over price.
-
Pricing Scenario (2023–2028):
| Year |
Price Range (USD/month) |
Comments |
| 2023 |
580–700 |
Stable, with discounts and rebates applied |
| 2024–2025 |
550–680 |
Slight decline expected due to increased market competition |
| 2026–2028 |
530–650 |
Stabilization as expanded indications drive volume |
Sales Projections
- 2023: USD 4.8 billion, steady with prior year.
- 2024–2025: Growth of 10–15% annually due to increased indications.
- 2026–2028: Mature market with modest growth of 5–8% annually as pricing stabilizes.
Impacts of Patent Status and Patent Expirations
- Patent Status: U.S. patent protections extend through 2028–2029.
- Potential for Generic Entry: Likely around 2029, leading to substantial price reductions.
Key Factors Affecting Market and Price
- Regulatory approvals for additional indications.
- Insurance coverage policies and formularies.
- Competitive dynamics with biosimilars and next-generation drugs.
- Clinical data demonstrating superior efficacy or safety.
Key Takeaways
- Farxiga faces competition but maintains a dominant position due to its expanded label.
- Current prices hover around USD 600 per month, with trends favoring slight decreases due to market saturation.
- Long-term price stability is contingent upon patent exclusivity, with significant discounts possible post-patent expiry.
- Sales are projected to grow until patent expiry, after which prices could decline sharply with generic entry.
FAQs
Q1: Will the price of Farxiga decrease significantly after patent expiry?
Yes. Historically, similar drugs experienced 50% or more price declines within two years of generic entry [5].
Q2: How do expanded indications influence pricing power?
Broader indications increase volume and perceived value, enabling manufacturers to sustain or slightly increase prices before patent expiry.
Q3: What are the main drivers of sales growth for Farxiga?
Expansion into heart failure and CKD, increasing patient adoption, and favorable reimbursement policies.
Q4: How competitive is the SGLT2 inhibitor market?
Highly competitive, with Emphasized brands like Jardiance and Invokana capturing substantial market share.
Q5: What factors could mitigate Price declines pre-patent expiry?
Limited generic competition, effective patent defenses, and exclusive distribution rights.
References
[1] Grand View Research. (2022). Diabetes Mellitus Market Size, Share & Trends.
[2] MarketsandMarkets. (2022). SGLT2 Inhibitors Market.
[3] IQVIA. (2022). Prescription Sales Data for SGLT2 Inhibitors.
[4] Public price listings and the Medicare formulary database.
[5] IMS Health. (2021). Post-patent drug pricing and market entry data.
Note: All figures are estimates based on market reports and public data as of Q1 2023.
