Last updated: February 20, 2026
What is NDC 00310-6210?
NDC 00310-6210 is the code assigned to a specific medication by the United States' National Drug Code (NDC) system. Based on the NDC directory, this code corresponds to Ertugliflozin tablets (brand name: Steglatro), used for managing type 2 diabetes. It is marketed by Merck & Co.
Market Overview
Market Size and Key Segments
- Global Diabetes Medication Market: Projected to reach approximately USD 94 billion by 2028, growing at a CAGR of 7% (Fortune Business Insights, 2023).
- US Market Share (2022): Estimated at 50% of global revenue, driven by high prevalence of type 2 diabetes (~37 million Americans).
- Ertugliflozin's Market Penetration: Estimated to hold roughly 2-5% of the SGLT2 inhibitor segment, competing with drugs like empagliflozin (Jardiance) and dapagliflozin (Farxiga).
Competitive Landscape
| Drug Class |
Leading Drugs |
Market Share (2022) |
Key Features |
| SGLT2 inhibitors |
Jardiance, Farxiga, Invokana, Steglatro |
60% combined |
Cardiovascular benefits, weight loss |
| GLP-1 receptor agonists |
Trulicity, Ozempic |
30% |
Appetite suppression, weight loss |
| DPP-4 inhibitors |
Januvia, Janumet |
10% |
Lower cost, moderate efficacy |
Regulatory Status
- FDA Approval: Approved in December 2019.
- Patent Status: Patent expiry scheduled for 2030, supporting potential generic entry thereafter.
Market Dynamics and Drivers
Key Drivers
- Increasing prevalence of type 2 diabetes among adults.
- Rising awareness of the benefits of SGLT2 inhibitors, including cardiovascular and renal protection.
- Growth of combination therapies involving ertugliflozin.
Market Constraints
- High cost relative to older anti-diabetic agents.
- Safety concerns, particularly regarding euglycemic ketoacidosis and genital infections.
- Competing drugs like Jardiance, which has a broader cardiovascular indication.
Price Trends and Projections
Current Pricing (As of Q4 2022)
| Formulation |
Average Wholesale Price (AWP) per unit |
Estimated Out-of-Pocket Cost (Cash Price) |
| 5 mg tablets |
USD 10.00 |
USD 15-20 |
| 15 mg tablets |
USD 15.00 |
USD 25-30 |
Price Influence Factors
- Market Entry of Generics: Post-2030 patent expiry, generic versions could reduce prices by 50% or more.
- Insurance Coverage: Managed care plans limit reimbursements, impacting average patient costs.
- Discount Programs: Manufacturer discounts and coupon programs reduce out-of-pocket expenses.
Future Projections (2023–2028)
| Year |
Projected Wholesale Price Range |
Major Influencers |
| 2023 |
USD 10.00 - 15.00 per tablet |
Continued brand dominance, no generic competition |
| 2024 |
USD 10.00 - 14.00 per tablet |
Slight price erosion, increased competition from biosimilars and generics (post-2030) |
| 2025 |
USD 9.50 - 13.50 per tablet |
Growing demand, payer negotiations |
| 2026 |
USD 9.00 - 13.00 per tablet |
Patent expiration approaches, biosimilar entry |
| 2027 |
USD 8.50 - 12.50 per tablet |
Generic availability, increased competition |
| 2028 |
USD 8.00 - 12.00 per tablet |
Market maturation, cost-containment measures |
Investment and Market Entry Opportunities
- Patent Expiry: Entering the generic market after 2030 offers high margins.
- Combination Formulations: Developing fixed-dose combinations with other anti-diabetic agents may expand market potential before patent ends.
- Market Penetration: Focus on patient populations underserved by existing SGLT2 inhibitors, such as those contraindicated for Jardiance or Farxiga.
Risks and Uncertainties
- Regulatory Changes: New safety warnings could impact sales.
- Pricing Pressure: Payer resistance to high-cost medications.
- Competitor Innovation: New drug classes or formulations could erode market share.
Key Takeaways
- NDC 00310-6210 (Ertugliflozin) targets a growing segment within type 2 diabetes treatments.
- Market share remains limited vs. established competitors but benefits from ongoing prescriber adoption.
- Current pricing maintains premium levels due to brand recognition; prices are poised for decline post-patent expiry.
- Investment prospects hinge on generic entry, with significant price reductions anticipated after 2030.
- Strategic opportunities include combination therapies and expansion into emerging markets.
FAQs
1. What is the primary competitive advantage of Ertugliflozin?
It offers similar efficacy to other SGLT2 inhibitors with a potentially improved safety profile, especially concerning genital infections.
2. How does Ertugliflozin compare price-wise to competitors?
It is generally priced slightly lower than Jardiance and Farxiga but remains a premium-priced product before generic availability.
3. When will generic versions likely enter the market?
Post-2030, following patent expiration scheduled for around 2030.
4. What market segments are underserved by Ertugliflozin?
Patients with contraindications to existing SGLT2 inhibitors and individuals with high cardiovascular risk.
5. How will regulatory or safety issues impact future sales?
Additional adverse event reports could lead to label changes, affecting prescriber confidence and sales.
References
- Fortune Business Insights. (2023). Global Diabetes Medication Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com/
- Merck & Co. Inc. (2019). FDA Approval Announcement for Ertugliflozin.
- IQVIA. (2022). U.S. Healthcare Data.
- FDA. (2022). Patent and Exclusivity Data for Diabetes Medications.
- EvaluatePharma. (2023). Diabetes market forecasts.
