Last updated: February 27, 2026
What is NDC 70000-0457?
NDC 70000-0457 is the National Drug Code used to identify a specific drug product. According to available databases, this NDC corresponds to Steglatro (ertugliflozin), a medication approved for the treatment of type 2 diabetes mellitus.
Market Overview
Therapeutic Area and Market Size
The global type 2 diabetes market was valued at approximately $87 billion in 2022 and is projected to reach $110 billion by 2027, growing at around 4.8% CAGR[^1]. Key drivers include increasing prevalence, diagnostic improvements, and the rising adoption of novel antidiabetic agents.
Key Competitors
- Dapagliflozin (Farxiga): Market leader with over $4.8 billion in global sales (2022).
- Empagliflozin (Jardiance): Over $3.9 billion in 2022.
- Canagliflozin (Invokana/Invokamet): Approximately $1.6 billion in 2022.
- Ertugliflozin (Steglatro): Launched in 2017, with estimated global sales around $300 million in 2022, indicating moderate market penetration.
Regulatory and Patent Landscape
- The patent for Steglatro expired in the U.S. in 2027, opening the market to generic competition.
- Pfizer, the manufacturer, holds exclusivity until patent expiration but filed for extensions in some jurisdictions.
Pricing and Reimbursement
Current Pricing
Exact wholesale acquisition costs (WAC) for NDC 70000-0457 vary by formulation and region.
| Formulation |
Estimated WAC Price (per month) |
Notes |
| 5 mg tablet |
$380 – $420 |
Estimated for the U.S. retail market |
| 15 mg tablet |
$380 – $420 |
Same as 5 mg, differing dose |
Prices have been relatively stable since launch but are expected to decline with generic entry.
Reimbursement Landscape
Insurance coverage predominantly favors established DPP-4 inhibitors and SGLT2 inhibitors like dapagliflozin and empagliflozin. Steglatro's market share is limited partially due to payer hesitations over incremental benefits.
Market Penetration and Growth Projections
Current Market Share
Steglatro accounts for less than 10% of the SGLT2 inhibitor market, with sales growth hampered by increased competition and generic entry.
Sales Forecast (2023-2028)
| Year |
Projected Sales (USD millions) |
Assumptions |
| 2023 |
~$200 |
Slight growth with existing brand presence |
| 2024 |
~$150 – $180 |
Decline as generics enter the market |
| 2025 |
<$100 |
Market erosion and increased competition |
| 2026 |
<$50 |
Generics dominate, minimal branded sales |
| 2027 |
~$10 – $20 |
Post-patent expiry, primarily generic sales |
Note: These projections assume generic entry begins in late 2026 and that Pfizer does not secure new patents or expedite reformulations.
Price Projection Dynamics
Post-patent expiration, generic versions are expected to reduce prices by 50-70%[^2].
| Year |
Estimated Price Range (per month) |
Market Factors |
| 2026 |
$200 – $250 |
Patent expiry approaches; generic availability expands |
| 2027 |
$100 – $150 |
Major generics enter the market, reduced brand value |
| 2028 |
<$100 |
Generics dominate; branded price drops further |
Strategic Factors
- Patent challenges: Generic manufacturers will pursue patent challenges to extend exclusivity.
- Market differentiation: Limited due to similar efficacy profiles of SGLT2 class drugs.
- Reimbursement trends: Payers favor drugs with proven cardiovascular and renal benefits, which may influence future pricing and formulary positioning.
Summary of Risks and Opportunities
| Risks |
Opportunities |
| Early generic competition |
Longer-term revenue potential from combination therapies |
| Payer resistance |
Entry into emerging markets as prices decline |
| Market saturation |
Development of new formulations or indications |
Key Takeaways
- NDC 70000-0457 (Steglatro) operates within a highly competitive and mature class.
- Sales are expected to decline sharply beginning in 2027 due to patent expiry.
- Prices will decrease substantially (>50%) post-patent, impacting revenue.
- Market share growth relies on differentiating benefits or combination therapy strategies.
- The overall market continues to grow, but Steglatro's market position diminishes with generic threats.
FAQs
1. When will generic versions of Steglatro be available?
Generic versions are anticipated to enter the U.S. market around late 2026 to early 2027, following patent expiration.
2. How will pricing change after patent expiry?
Prices are expected to decrease by 50-70%, roughly reducing the current monthly cost from approximately $400 to under $150.
3. What is the growth outlook for the SGLT2 inhibitor class?
Global sales are projected to grow at a CAGR of about 4.8%, reaching over $110 billion by 2027, driven by diabetes and cardiovascular indications.
4. How does Steglatro compare to other SGLT2 inhibitors?
It has a similar efficacy profile but holds less market share due to late market entry and less extensive cardiovascular benefit data compared to empagliflozin and dapagliflozin.
5. What strategic moves can Pfizer pursue to extend product revenue?
Focus on combination therapies, expanding indications, and research into cardiorenal benefits may sustain sales beyond patent expiry.
References
[1] GlobalData. (2022). Diabetes Market Report, 2022-2027.
[2] IQVIA. (2022). The Impact of Patent Expirations on Drug Pricing.
