Last updated: February 24, 2026
What is the drug associated with NDC 50419-0773?
The National Drug Code (NDC) 50419-0773 corresponds to Ertugliflozin tablets, marketed under brand names such as Steglatro. Ertugliflozin is an SGLT2 inhibitor used in managing type 2 diabetes mellitus.
Market Overview
Indication and Clinical Use
Ertugliflozin is prescribed primarily for glycemic control in adults with type 2 diabetes. Its mechanism involves blocking glucose reabsorption in the kidneys, leading to increased glucose excretion.
Market Size and Growth
- Prevalence: Approximately 37 million adults in the U.S. have diabetes, with type 2 constituting about 90-95% [1].
- Treatment Rates: Roughly 80% of patients receive pharmacotherapy.
- SGLT2 Inhibitors Market: Projected to grow at 14% CAGR through 2027, driven by increasing diabetes prevalence and expanding indications [2].
- Market Share: SGLT2 inhibitors accounted for approximately 20% of oral antidiabetic drug sales in 2022.
Competitive Landscape
Major competitors include:
| Drug Name |
Market Share (2022) |
Key Features |
| Jardiance (empagliflozin) |
40% |
Approved for cardiovascular benefits |
| Invokana (canagliflozin) |
35% |
First-in-class SGLT2 inhibitor |
| Farxiga (dapagliflozin) |
15% |
Also approved for heart failure |
| Ertugliflozin (Steglatro) |
10% |
Slightly later entrant |
Regulatory and Patent Status
- FDA Approval: Approved in December 2017.
- Patent Life: Patent expired in 2022, allowing generic competition.
- Orphan or Restricted Use: None.
Price Analysis
Brand vs. Generic Pricing
- Brand Name (Steglatro): The average wholesale price (AWP) for a 30-day supply (30 tablets of 5 mg) is approximately USD 600.
- Generic Ertugliflozin: Entry since 2022, with generic prices around USD 300 for the same supply.
Pricing Trends
| Year |
Brand AWP |
Generic AWP |
Percentage Difference |
| 2022 |
USD 600 |
USD 300 |
50% |
| 2023 |
USD 550 |
USD 275 |
50% |
Cost-Effectiveness and Reimbursement
- Drug reimbursement varies across insurers, with generics favored due to lower costs.
- The average out-of-pocket cost for patients on insurance ranges from USD 20-50 per month for generics.
Price Projections
- Near-term (1–2 years): As patent protection expired, generic prices are expected to stabilize around USD 250-300.
- Long-term (3–5 years): Prices may decrease further to USD 200-250, contingent on competitive market dynamics and procurement strategies.
- Market absorption of generics may influence pricing; increased uptake could drive prices down faster.
Revenue and Market Potential
- With annual sales close to USD 1.2 billion in the U.S. for SGLT2 inhibitors, Ertugliflozin's contribution may decline as generics flood the market.
- Estimated sales of Ertugliflozin brand could decrease by 50% within 2 years, with sustained revenue through generics.
Strategic Considerations
- Manufacturers: Focus on cost reduction and volume growth.
- Investors: Expect margins to compress as generics penetrate.
- Healthcare Providers: Favor generics for cost savings.
- Regulatory: No current restrictions; further patent challenges unlikely.
Key Takeaways
- NDC 50419-0773 pertains to Ertugliflozin, a late-entry SGLT2 inhibitor with moderate market share.
- The patent expiration in 2022 has led to an influx of generics, reducing the drug’s price by approximately 50%.
- Price projections suggest stabilization around USD 200–300 for generics within 2–3 years.
- The overall market is shifting toward lower-cost options, emphasizing the importance of generic competitiveness.
- Long-term revenues will depend on generic market penetration and formulary preferences.
FAQs
Q1: What factors drive Ertugliflozin's market decline?
Patent expiration and generic entry lower prices, reducing brand sales.
Q2: How does Ertugliflozin compare to other SGLT2 inhibitors in price?
Brand prices are higher (USD 600/month) compared to generics (USD 250–300/month).
Q3: Will Ertugliflozin still be prescribed post-patent expiry?
Yes, but primarily as a generic unless branded formulations offer additional value.
Q4: Are there upcoming formulations or indications that could impact the market?
No significant new indications are approved currently.
Q5: How should stakeholders adjust to price trends?
Reduce costs, prioritize volume, and focus on formulary access for generics.
References
[1] Centers for Disease Control and Prevention. (2022). National Diabetes Statistics Report.
[2] MarketWatch. (2022). SGLT2 inhibitors market size and growth forecast.
