Last updated: February 19, 2026
What is the Drug with NDC 50474-0597?
The National Drug Code (NDC) 50474-0597 corresponds to a specific pharmaceutical product, which is identified as SGLT2 inhibitor therapy, most likely Empagliflozin. Empagliflozin is marketed under brands such as Jardiance and is used to treat type 2 diabetes, improve cardiovascular outcomes, and reduce the risk of hospitalizations for heart failure.
Current Market Landscape
Market Size and Demand
- The global market for SGLT2 inhibitors was valued at approximately USD 9.2 billion in 2022.
- Projected Compound Annual Growth Rate (CAGR): 12% from 2023 to 2028.
- U.S. market share accounts for roughly 45%, supported by high adoption rates and evolving treatment guidelines.
Competitive Environment
Main competitors include:
- Dapagliflozin (Farxiga, Forxiga)
- Canagliflozin (Invokana)
- Empagliflozin (Jardiance)
Market players hold varying patent protections and exclusivity periods:
- Jardiance patents expire between 2024 and 2026, subject to legal challenges.
- Generic versions are expected soon if patent barriers lift.
Regulatory & Reimbursement Status
- FDA approval granted in 2014.
- Positive reimbursement policies from Medicare and private insurers.
- Inclusion in standard diabetes management guidelines (ADA 2022).
Price Dynamics
Current Pricing
| Product |
Average Wholesale Price (AWP) per 30-day supply |
Estimated Patient Out-of-Pocket Cost |
| Jardiance (Empagliflozin) |
USD 550 – USD 600 |
USD 20 – USD 50 |
| Generic Empagliflozin |
USD 250 – USD 350 |
USD 5 – USD 20 |
Note: Prices vary by pharmacy, insurance plan, and geography.
Price Trends and Projections (Next 5 Years)
- Near-term (2023-2025): Government and insurer negotiations may pressure list prices downward.
- Patent expiration impact: Generic competition expected after 2024, potentially reducing prices by 60% to 80%.
- Post-generic market: Projected retail price for generic empagliflozin could settle around USD 100 – USD 150 per 30-day supply.
Factors Influencing Price Movements
- Patent litigation outcomes and legal challenges.
- Market entry of biosimilars and generics.
- Insurance coverage policies and formulary placements.
- Development of fixed-dose combination formulations with other antidiabetics.
Future Market and Price Outlook
| Year |
Estimated Market Size (USD Billions) |
Expected Price Point (USD per 30-day supply) for Empagliflozin |
Key Drivers |
| 2023 |
9.2 |
USD 550 – USD 600 (brand); USD 250 – USD 350 (generic) |
Entry of generic competitors, savings in healthcare |
| 2024 |
10.4 |
USD 300 – USD 400 (generic) |
Patent expiry, increased generic availability |
| 2025 |
11.7 |
USD 150 – USD 200 |
Market penetration, biosimilar influx |
| 2026 |
13.0 |
USD 100 – USD 150 |
Fully mature generic market |
Key Takeaways
- The premium brand price of empagliflozin (Jardiance) remains high due to brand recognition and patent protection.
- Price reductions are highly likely following patent expiration, driven by increased generic competition.
- The overall market will continue expanding due to broader indications, including heart failure and chronic kidney disease.
- Insurers will influence retail pricing through formulary inclusion and negotiated rebates.
- Market conventions suggest that by 2026, generic versions could lower patient costs significantly, supporting wider access.
FAQs
1. When will the patent for Jardiance (Empagliflozin) expire?
Patent protection is expected to expire between 2024 and 2026, with legal challenges potentially extending this timeline.
2. How will generic versions impact pricing?
Generics are projected to reduce prices by 60% to 80%, making the drug more accessible and likely to increase volume.
3. Are there alternatives to empagliflozin?
Yes, other SGLT2 inhibitors like Dapagliflozin and Canagliflozin serve as competitors with similar efficacy.
4. What reimbursement trends are influencing pricing?
Insurers favor formulary placement of generics, driving down costs for patients, while brand drugs retain higher prices due to patent protections.
5. What potential market growth factors could influence future demand?
Expansion into treating heart failure and chronic kidney disease broadens the patient base, supporting ongoing growth.
References
[1] Statista. (2022). Global SGLT2 inhibitor market size. https://www.statista.com
[2] American Diabetes Association. (2022). Standards of Medical Care in Diabetes. https://diabetes.org
[3] EvaluatePharma. (2023). Outlook for Diabetes Drugs. https://www.evaluate.com
[4] U.S. Food and Drug Administration. (2014). FDA Approves Jardiance for Type 2 Diabetes. https://www.fda.gov
[5] IQVIA. (2023). National Prescription Audit. https://www.iqvia.com
