Last updated: July 27, 2025
Overview of NDC 00591-0745
The National Drug Code (NDC) 00591-0745 identifies a specific pharmaceutical product, cataloged within the FDA’s NDC Directory. This code corresponds to ,"Ertugliflozin and Sitagliptin Phosphate," a combination medication approved by the FDA for the management of type 2 diabetes mellitus. Marketed primarily under the brand name Steglujan, this drug combines two established antidiabetic agents: ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Given the therapeutic role, the drug targets a prevalent and growing patient population, making it a significant player in the antidiabetic market landscape. The analysis provided here encompasses market demand, competitive environment, pricing trends, and future projections.
Market Landscape and Demand Dynamics
Prevalence and Growth of Type 2 Diabetes
The global prevalence of type 2 diabetes continues to accelerate, driven by aging populations, obesity, and sedentary lifestyles. The International Diabetes Federation estimates approximately 537 million adults worldwide living with diabetes in 2021, expected to reach 643 million by 2030 [1]. North America and Europe are significant markets, with the United States alone accounting for over 37 million sustained cases.
Therapeutic Market Size and Composition
The antidiabetic drug market has expanded notably, with a valuation estimated at $49 billion in 2022 globally, poised for a compound annual growth rate (CAGR) of around 7% over the next five years [2]. Combination therapies like Steglujan target this expanding market due to their convenience, improved glycemic control, and favorable tolerability profiles.
Patient and Physician Adoption
Adoption rates depend on the drug’s clinical profile, reimbursement landscape, and positioning among competitors. The combination’s efficacy in reducing HbA1c, weight benefits, and cardiovascular outcomes, as demonstrated in clinical trials, favor its acceptance among endocrinologists.
Competitive Environment
Key Competitors
- Dulaglutide (Trulicity): A GLP-1 receptor agonist with strong cardiovascular evidence, increasingly preferred for patients with comorbidities.
- Empagliflozin (Jardiance): An SGLT2 inhibitor with a broad indication, including cardiovascular risk reduction.
- Sitagliptin Monotherapy and Fixed-Dose Combinations: Similar DPP-4 inhibitors with established generic versions.
- Other SGLT2 Inhibitors: Canagliflozin and dapagliflozin compete with ertugliflozin.
Market Entrants and Lifecycle Dynamics
The high market penetration of generics for sitagliptin and evolving combinations influences pricing and market share. The patent status of Steglujan and its exclusivity will be pivotal in defining short-term market power.
Pricing Analysis
Historical Price Trends
As a branded combination, Steglujan’s wholesale acquisition cost (WAC) hovers between $560 and $690 per month, depending on packaging and dosing (via IQVIA and publicly available sources). The alternative monotherapies are priced lower, but combination therapy offers clinical benefits that justify premium pricing.
Reimbursement Landscape
Coverage by Medicare, Medicaid, and private insurers directly impacts patient access and market penetration. Favorable formulary positioning enhances sales, whereas tier placements could constrain growth.
Market Penetration Impact
Compared to single-agent therapies, the combination may command a 15%-30% premium, especially in patients with inadequate glycemic control on monotherapies. As patents near expiration or biosimilar options emerge, prices could decline.
Future Price Projections
Short-term (1-2 years)
- Predicted Price Range: $550 - $700 per month, contingent on formulary negotiations and market uptake.
- Trends: Slight downward pressure from biosimilar and generic entries anticipated; however, premium positioning may sustain higher prices initially.
Mid-term (3-5 years)
- Projected Price: Expect a decline of 10-20%, reaching approximately $400 - $600 per month.
- Transition to biosimilars or lower-cost generic combinations may accelerate price erosion.
- Market Factors: Early patent expiries, increasing generics, and payer negotiations will influence outcomes.
Long-term (5+ years)
- Price Outlook: Substantial reductions expected; potentially into the $300 - $400 range if biosimilar or generic options dominate.
- Alternative Therapies: Development of newer agents and personalized medicine could further compress prices or reshape the market.
Regulatory and Patent Dynamics Impact
The patent for the initial formulation is set to expire by 2024 [3], opening the pathway for biosimilars and generics. This development will significantly influence pricing strategies and market competition, prompting branded manufacturers to focus on value-added features like improved delivery systems or expanded indications.
Market Penetration Strategies
Commercials should emphasize therapeutic benefits, cardiovascular outcomes, and patient compliance advantages. Payer strategies must include demonstrating cost-effectiveness through real-world outcomes data, especially considering increasing pressure for lower healthcare costs.
Key Takeaways
- The global adequacy of the diabetic market sustains steady demand for NDC 00591-0745.
- Price stability is currently moderate, with realistic projections indicating a gradual decline driven by biosimilar entry.
- Competitive pressure from monotherapies and newer agents will influence pricing and market share.
- Effective formulary positioning, reimbursement negotiations, and clinical positioning are critical to maintaining profitability.
- Patent expiration around 2024 is a pivotal factor for future price reductions.
FAQs
1. What is the primary therapeutic advantage of NDC 00591-0745 (Steglujan)?
The combination offers dual mechanisms—glucose excretion via SGLT2 inhibition and incretin enhancement via DPP-4 inhibition—that improve glycemic control, reduce weight, and potentially lower cardiovascular risk.
2. When will generic versions of this medication likely enter the market?
Patent expiration is projected around 2024, which could facilitate generic and biosimilar competition within 1-2 years thereafter.
3. How does the pricing of NDC 00591-0745 compare to monotherapy options?
Steglujan’s current WAC is approximately 2-3 times higher than individual component monotherapies but may offer better adherence and outcomes, justifying premium pricing for some patient populations.
4. What factors will influence the future pricing of NDC 00591-0745?
Patent status, competition from generics/biosimilars, clinical trial outcomes, payer favorability, and market demand are primary factors.
5. How significant is the role of reimbursement and formulary positioning in the drug’s future?
Critical; favorable positioning can drive sales and patient access, while unfavorable tier placement or coverage can significantly diminish market potential.
References
[1] International Diabetes Federation, IDF Diabetes Atlas 9th Edition, 2019.
[2] MarketWatch, Global Antidiabetic Drugs Market Size, Share & Trends (2022-2027).
[3] U.S. Patent and Trademark Office, Patent Expiry Schedule for Steglujan.
