Last updated: February 19, 2026
What is NDC 68382-0331?
NDC 68382-0331 corresponds to Empagliflozin, marketed under the brand name Jardiance by Eli Lilly/Boehringer Ingelheim. It is approved for type 2 diabetes management and has expanded indications, including reduction of cardiovascular death risk in adult patients with heart failure with reduced ejection fraction.
Current Market Position
Empagliflozin captures a significant share within the SGLT2 inhibitor class, which includes drugs like canagliflozin (Invokana) and dapagliflozin (Farxiga). The drug's approval for heart failure broadens its market potential beyond diabetes.
Market Size (2022-2023)
| Metric |
Data |
Source |
| U.S. diabetes market (2022) |
$20 billion |
IQVIA |
| SGLT2 inhibitors share of diabetes market |
25% |
Evaluate Pharma |
| Empagliflozin's market share |
8-10% of SGLT2 class |
IQVIA |
Worldwide, SGLT2 inhibitor sales doubled from 2020 to 2022, reaching approximately $10 billion in global revenue.
Key Competitors
- Dapagliflozin (Farxiga)
- Canagliflozin (Invokana)
- Ertugliflozin (Steglatro)
Empagliflozin's higher approval profile for cardiovascular outcomes offers a potential competitive advantage.
Patent and Patent Expiry
Patent expiry scheduled for 2030 for U.S. composition of matter, with some formulations or combinations potentially extending protections until 2035 due to secondary patents.
Market Trends and Drivers
- Growth of the diabetes population: 37 million in the U.S., projected to reach 55 million by 2030.
- Rising adoption of SGLT2 inhibitors for heart failure and CKD.
- Expanded label indications for cardiovascular and renal benefits.
Price Trends and Projections
Current Pricing (2023)
- Average Wholesale Price (AWP): $500 - $600/month per patient.
- Patient Out-of-Pocket Cost: $50 - $150/month, depending on insurance.
Pricing Factors
- Competition drives price erosion.
- Patent protections limit generic entry until post-2030.
- Insurance coverage and PBM negotiations influence net prices.
Price Projections (Next 5 Years)
| Year |
Expected Average Wholesale Price |
Major Factors Influencing Price |
Source / Rationale |
| 2023 |
$550 |
Current market rates |
Based on recent wholesale data |
| 2024 |
$530 |
Patent expiry approaches, biosimilar entry risk |
Competitive pressure expected to slightly reduce price |
| 2025 |
$510 |
Increased biosimilar development |
Industry trend towards reduced prices with biosimilar competition |
| 2026 |
$490 |
Biosimilars entering in select markets |
Global biosimilar launches impact pricing |
| 2027 |
$470 |
Greater biosimilar/damage to innovator pricing |
Industry consensus |
Price Sensitivity and Market Share
Price reductions of 10-20% could result in increased medication uptake due to higher affordability, potentially offsetting revenue declines.
Regulatory and Policy Impact
- Increased emphasis on cost-effective care may pressure price reductions.
- Negotiations with Medicare and private payers aim to lower drug costs.
- Reimbursement policies favor drugs with proven cardiovascular/renal benefits.
Risks to Market and Price Outlook
- Accelerated biosimilar/generic entry post-2030.
- Changes in clinical guidelines affecting prescribing patterns.
- Competition from new SGLT2 inhibitors with improved profiles.
Key Takeaways
- Empagliflozin's market is driven by its cardiovascular and renal benefits, expanding its use beyond diabetes.
- The drug maintains a strong market position but faces price pressure from biosimilars post-2030.
- Current prices are around $550 per month, with forecasts indicating a gradual decline to approximately $470 by 2027.
- Increased use in heart failure and CKD may sustain revenue growth despite price erosion.
- Price sensitivity could lead to higher adoption if costs decrease.
FAQs
1. When is patent expiration for NDC 68382-0331?
Primarily 2030 in the U.S., with secondary patents potentially extending protection until 2035.
2. What are the main competitors of empagliflozin?
Dapagliflozin (Farxiga), canagliflozin (Invokana), and ertugliflozin (Steglatro).
3. How is the expanding indication for heart failure affecting market potential?
It broadens the patient population beyond diabetes, potentially increasing sales volume.
4. What factors could accelerate price reductions?
Entry of biosimilars, increased negotiations with payers, and shifts in clinical practice guidelines.
5. How does insurance coverage influence net prices?
Insurance negotiations and formulary placements significantly impact the actual cost paid by patients and providers.
References
[1] IQVIA. (2023). U.S. prescription drug market data.
[2] Evaluate Pharma. (2022). Global SGLT2 inhibitor sales overview.
[3] U.S. Food and Drug Administration. (2022). Approvals and patent information for empagliflozin.
[4] MarketWatch. (2023). Industry pricing trends and biosimilar impact projections.
