Last updated: March 11, 2026
What is the drug associated with NDC 60429-0967?
NDC 60429-0967 corresponds to Ertugliflozin, marketed under the brand name Steglatro. It is an SGLT2 inhibitor used in managing type 2 diabetes mellitus. It was approved by the FDA in December 2017.
What is the current market landscape for Ertugliflozin?
The global type 2 diabetes market was valued at approximately $78 billion in 2021 and is projected to reach $135 billion by 2027, with a compound annual growth rate (CAGR) of 8.2% [1].
Key competitors include:
- Empagliflozin (Jardiance): Market leader, with a 2022 sales volume of approximately $4.2 billion.
- Dapagliflozin (Farxiga): Sales close to $2.8 billion in 2022.
- Canagliflozin (Invokana): Sales approximately $1.7 billion in 2022.
Ertugliflozin entered a competitive market with established players. Its initial sales in 2022 were estimated at around $200 million, with growth potential as prescriber familiarity increases.
Market share estimates (2022):
| Drug |
Estimated Sales ($ millions) |
Market Share (%) |
| Jardiance |
4,200 |
65.6 |
| Farxiga |
2,800 |
43.8 |
| Invokana |
1,700 |
26.6 |
| Ertugliflozin |
200 |
3.1 |
(Note: Overlap occurs due to combined prescription data; the figures are approximations for specific products.)
What are the pricing trends?
Current pricing structure:
- Monthly wholesale acquisition cost (WAC): Approximately $500 for a 30-day supply of 5mg or 15mg doses (per Martin et al., 2022).
- Average patient out-of-pocket cost: Estimated at $10–$50 per month, depending on insurance coverage.
Price trends:
- Prices have declined modestly since launch, driven by increased market competition and payer negotiations.
- Generic options are not available as of 2023, keeping the brand name drugs at premium pricing.
Price projections for the next 5 years:
| Year |
Estimated WAC per month |
Notes |
| 2023 |
$500 |
Current levels |
| 2024 |
$480 |
Slight decrease due to competitive pressures |
| 2025 |
$460 |
Continued market saturation |
| 2026 |
$440 |
Potential entry of biosimilars or generics? |
| 2027 |
$420 |
Possible price stabilization or further reduction |
What factors influence future market dynamics?
- Regulatory developments: Approval of biosimilars or new indications can alter demand.
- Patent expiry: Patent protections are expected to last until at least 2026, potentially opening the market for generics afterward.
- Market penetration: Physician acceptance, formulary placement, and patient adherence will influence sales growth.
- Pricing strategies: Payer negotiations and rebate structures will shape net prices.
What is the projected revenue for Ertugliflozin?
Assuming:
- Market penetration increases to 10% of the type 2 diabetes patient population (estimated at 37 million in the U.S.).
- An average of 500,000 patients on Ertugliflozin annually.
- An average monthly cost of $480 (projected decline).
Annual revenue estimate:
- ( 500,000\, \text{patients} \times \$480 \times 12\, \text{months} = \$2.88\, \text{billion} )
However, adjusting for market share, payer restrictions, and competition likely reduces realizable revenue.
Realistic projection:
- Year 2023: approximately $200 million.
- Year 2025: growing to around $400–$600 million.
- Year 2027: approaching $800 million, assuming steady market share increase.
Key takeaways
- NDC 60429-0967 (Ertugliflozin) is in a competitive SGLT2 inhibitor market that is growing but dominated by established brands.
- Current pricing remains high due to the lack of generics, with slow reductions projected.
- Revenue growth depends on prescriber acceptance, formulary access, and market penetration, with estimates reaching nearly $1 billion by 2027.
FAQs
1. How does Ertugliflozin's efficacy compare to other SGLT2 inhibitors?
Ertugliflozin offers comparable glycemic control and cardiovascular benefits as other SGLT2 inhibitors like Jardiance and Farxiga, as demonstrated in clinical studies (Vangoitsenhoven et al., 2020).
2. What are the main barriers to market expansion for Ertugliflozin?
Barriers include strong competition from established brands, payer hesitations due to pricing, and limited differentiating features from competitors.
3. When is patent expiration expected for Ertugliflozin?
Patent protections are expected to last until 2026, facilitating the potential entry of generics thereafter.
4. How are payer negotiations impacting Ertugliflozin pricing?
Rebate agreements and formulary placements are expected to reduce net prices over time, pressuring the list prices downward.
5. Are there upcoming regulatory or patent developments affecting this drug?
No scheduled regulatory changes or patent expirations are expected before 2026, with potential biosimilar approval afterward influencing the market.
References
[1] Grand View Research. (2022). Type 2 Diabetes Market Insights. Retrieved from https://www.grandviewresearch.com/industry-analysis/type-2-diabetes-market
