Last updated: February 24, 2026
What is NDC 00781-2329?
NDC 00781-2329 refers to Empagliflozin, marketed as Jardiance, a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to treat type 2 diabetes mellitus and reduce cardiovascular mortality in high-risk patients. It was approved by the FDA in 2014.
Market Overview
Current Market Size and Growth
- Global diabetes medication market value in 2022: approximately USD 55 billion.
- SGLT2 inhibitors hold about 20% of this market.
- Empagliflozin's share within the SGLT2 class is estimated at 35% (by sales volume).
Key Competitors
| Drug |
Brand Name |
Approval Year |
Indication(s) |
Market Share (est.) |
| Empagliflozin |
Jardiance |
2014 |
Diabetes, CV risk |
35% |
| Canagliflozin |
Invokana |
2013 |
Diabetes |
25% |
| Dapagliflozin |
Farxiga |
2014 |
Diabetes, HF |
21% |
| Ertugliflozin |
Steglatro |
2017 |
Diabetes |
6% |
Revenue (2022)
- Empagliflozin: USD 3.2 billion globally.
- Growing at a compounded annual growth rate (CAGR) of 12% (2018-2022).
Geographic Market Penetration
- North America: 55% of sales.
- Europe: 25%.
- Rest of world: 20%.
Drivers of Market Growth
- Expanding indications, including heart failure and chronic kidney disease.
- Increasing adoption due to proven cardiovascular benefits.
- Rising prevalence of type 2 diabetes, projected to reach 700 million globally by 2045.
Regulatory and Patent Landscape
- Patent expiration in the U.S.: Scheduled for 2029 for formulation patents.
- The European patent expired in 2022, leading to increased biosimilar entry.
- Regulatory approvals for new indications (e.g., heart failure) can extend market exclusivity via label expansion.
Price Trends and Projections
Current Pricing
| Region |
Average Wholesale Price (AWP) per month |
Estimated Rebate/Discount |
Net Price |
| U.S. |
USD 600 |
20% |
USD 480 |
| EU |
EUR 500 |
15% |
EUR 425 (~USD 455) |
Factors Affecting Price
- Patent status influences pricing power.
- Entry of biosimilars or generics post-patent expiration.
- Negotiated discounts in payor contracts.
- Expanded indications increase utilization and influence pricing strategies.
Price Projection (2023-2028)
- Short-term (2023-2024): Prices will remain stable in major markets due to patent exclusivity. Anticipate slight increases (3-5%) driven by inflation and demand.
- Mid-term (2025-2026): Patent expiration approaches; biosimilar competition could reduce prices by 30-40%. Market share for biosimilars likely to reach 25-30% in the U.S.
- Long-term (2027-2028): Post-patent, net prices could fall to USD 250-350 per month as biosimilars and generics penetrate the market.
Market Entry of Biosimilars
- No biosilmar for empagliflozin yet.
- Biosimilars for the SGLT2 class are in clinical development, with potential entry within 2-3 years post-patent expiry.
- Price competition could significantly reduce costs in the U.S. and Europe.
Future Market Drivers and Risks
Drivers
- Expanded indications such as heart failure and chronic kidney disease.
- Increased use in non-diabetic populations.
- Price reductions incentivized by healthcare policies aiming to contain costs.
Risks
- Patent litigation or delays could extend exclusivity.
- Regulatory barriers or safety concerns related to new indications.
- The emergence of competing drug classes (e.g., GLP-1 receptor agonists).
Summary of Price and Market Forecasts
| Year |
Estimated Market Size |
Key Price Point |
Notes on Market Share and Competition |
| 2023 |
USD 3.2 billion |
USD 480/month net |
Dominance maintained, slight price hikes |
| 2024 |
USD 3.57 billion |
USD 480/ •month |
Market steady with volume growth |
| 2025 |
USD 3.96 billion |
USD 350-450/month |
Patent expiry signals beginning of price decline |
| 2026 |
USD 4.36 billion |
USD 250-350/month |
Biosimilars gaining market share |
| 2027 |
USD 4.8 billion |
USD 250/month |
Significant biosimilar presence |
Key Takeaways
- Empagliflozin remains a leading SGLT2 inhibitor with strong sales driven by expanding indications.
- Pricing will hold stable until patent expiration, after which biosimilars are expected to sharply reduce prices.
- The total market size is projected to grow at a CAGR of roughly 12% through 2028.
- The entry of biosimilars and expanded approved indications will influence both revenue and pricing strategies.
FAQs
1. When will biosimilars for empagliflozin enter the market?
Biosimilars are likely to launch 2-3 years after patent expiration, anticipated around 2029-2031.
2. How will patent expiration affect empagliflozin prices?
Prices are expected to decrease by approximately 30-40%, influenced by biosimilar competition and payer negotiations.
3. Are there regulatory hurdles for new indications?
Yes, expanded indications require additional clinical trials and regulatory approval, potentially delaying entry and market growth.
4. What are the primary drivers of market growth?
Expanding indications (e.g., heart failure, CKD), increasing prevalence of diabetes, and cardiovascular benefits.
5. How does geographic variation impact pricing?
In the U.S., prices are higher due to brand positioning and less price regulation; Europe experiences more aggressive price negotiations and discounts.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2014). Approval note for Jardiance (Empagliflozin).
- EvaluatePharma. (2022). Market forecasts for SGLT2 inhibitors.
- European Medicines Agency. (2022). Regulatory status for empagliflozin.
- Biosimilar Market Report. (2023). Development pipeline and entry timelines.
