Last updated: March 12, 2026
What is NDC 62011-0097?
NDC 62011-0097 corresponds to the drug Empagliflozin. It is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes mellitus. Empagliflozin is marketed under the brand name Jardiance by Boehringer Ingelheim in the United States.
Market Size and Demand Drivers
United States Market
- Diabetes Prevalence: Approximately 37.3 million Americans diagnosed with diabetes (CDC, 2020).
- Empagliflozin Penetration: Estimated that around 25% of prescriptions for SGLT2 inhibitors are for empagliflozin (IQVIA, 2022).
- Growth Trends: The global SGLT2 inhibitor market is expected to grow at a CAGR of 20% from 2022 to 2027 [1].
Key Factors
- Shift toward SGLT2 inhibitors due to cardiovascular and renal benefits.
- Increasing awareness and diagnosis of type 2 diabetes.
- Expanded indications including heart failure and chronic kidney disease.
Competition
- Main rivals: Dapagliflozin (Farxiga), Canagliflozin (Invokana), Ertugliflozin (Steglatro).
- Market share (2022): Empagliflozin holds roughly 30% of the SGLT2 market in the US.
Price Landscape and Projections
Current Pricing (as of 2023)
| Product |
Average Wholesale Price (AWP) per 30-day supply |
Patient Out-of-Pocket Cost |
Market Share |
| Jardiance (empagliflozin) |
$600 |
$15-$60 (copay) |
30% |
| Farxiga (dapagliflozin) |
$600 |
$15-$60 |
25% |
| Invokana (canagliflozin) |
$650 |
$20-$70 |
20% |
| Steglatro (ertugliflozin) |
$610 |
$15-$50 |
10% |
Note: Prices are approximate retail wholesale averages; actual patient costs vary by insurance plan.
Future Price Trends
- Patent Status: Expiration of Boehringer Ingelheim's patent for Jardiance is projected around 2030. Loss of exclusivity could reduce prices by 30–50%, assuming generic competition enters the market.
- Market Competition: Introduction of generics typically reduces brand prices; initial decreases may begin within 1–2 years of patent expiry.
Impact of Policy and Negotiations
- Medicare and Medicaid: Price negotiations could influence rates; recent reforms aim to lower prescription costs.
- Biosimilar Entry: Limited by drug complexity, biosimilar options are unlikely, but generic versions of small-molecule drugs are progressing.
Price Projection Timeline
| Year |
Price Range (per 30-day supply) |
Key Factors |
| 2023 |
$600–$650 |
Stable with current market share |
| 2025 |
$580–$630 |
Slight downward pressure from market competition |
| 2027 |
$540–$600 |
Increased competition anticipated, especially with patent expiration |
| 2030+ |
$300–$400 (with generics) |
Potential entry of generics following patent expiry, leading to price erosion |
Key Takeaways
- Empagliflozin's market remains robust due to cardiovascular and renal benefits.
- The drug holds roughly 30% of the US SGLT2 market.
- Prices are stable but expected to decrease from 2025 onward, especially post-patent expiry in 2030.
- Competition from Dapagliflozin and Canagliflozin influences price stability.
- Market expansion into non-diabetic conditions (heart failure, CKD) could sustain demand and prices temporarily.
FAQs
1. How vulnerable is empagliflozin to generic competition?
Price declines are expected post-2030 with patent expiration, reducing prices by 30–50%. Currently, no generics exist. Market share could shift toward generics, impacting brand valuations.
2. What factors drive price changes of empagliflozin?
Patent status, market penetration, insurance negotiations, and competition from other SGLT2 inhibitors. Policy reforms targeting drug prices can also influence retail costs.
3. Are there upcoming regulatory changes affecting the drug market?
Potential regulations aimed at drug pricing transparency and negotiation may pressure prices downward. No new approvals are expected to alter pricing dynamics significantly in the next two years.
4. What are the prospects for expanding empagliflozin's indications?
Recent data support use for heart failure and chronic kidney disease management, which may increase demand but do not substantially change pricing before patent expiration.
5. How does the market share of empagliflozin compare to competitors?
Empagliflozin holds approximately 30% of the US SGLT2 inhibitor market, second only to Dapagliflozin at around 35% as of 2022.
References
[1] Global Market Insights. (2022). SGLT2 Inhibitors Market Size, Share & Trends. Retrieved from https://www.gminsights.com/industry-analysis/sodium-glucose-co-transporter-2-sglt2-inhibitors-market
