Last updated: February 25, 2026
Overview:
NDC 00088-2102 corresponds to the drug Empagliflozin, marketed under the brand name Jardiance. It is an SGLT2 inhibitor used primarily for type 2 diabetes management. The drug also has indications for reducing cardiovascular mortality in adults with heart failure.
Market Landscape
Current Market Size
Empagliflozin’s global sales reached approximately $3.8 billion in 2022. Its primary markets include the U.S., Europe, and Japan.
Key Competitors
- Canagliflozin (Invokana)
- Dapagliflozin (Farxiga) / Forxiga
- Ertugliflozin (Steglatro)
Market Share Breakdown (2022)
| Product |
Market Share |
Sales (USD Billions) |
Notes |
| Empagliflozin |
45% |
1.7 |
Premium pricing, cardiovascular benefits |
| Canagliflozin |
30% |
1.1 |
First approved, broad label |
| Dapagliflozin |
20% |
0.7 |
Also indicated for heart failure |
| Others |
5% |
0.2 |
Less established products |
Patent and Exclusivity Status
Empagliflozin's primary patents expired or are expiring shortly, opening the market to generics. Patent cliff expected by 2024-2026, depending on jurisdictions.
Regulatory Developments
- FDA approved additional indication for heart failure in July 2022.
- EMA approved label expansion for diabetic kidney disease in early 2023.
Price Dynamics
Current Pricing (2023)
Average wholesale prices (AWP) for a 30-day supply are approximately:
- Brand Name (Jardiance USA): $550
- Generic (post-patent expiry): expected to drop to $350-$400
Historical Price Trends
- Brand price (2018): ~$600 per 30-day supply
- Price reduction trends align with patent expiration and increased generic competition.
Discounting and Rebates
- Actual prices paid by payers often reflect rebates, estimated at 20-30% reductions.
Price Projections
Short-Term (2023-2025)
- With patent expiry approaching, generic versions could enter the market by late 2024.
- Price decline of 20-30% anticipated for generics compared to branded due to increased competition and market saturation.
- Brand prices will likely stabilize around $500-$550 until patent loss leads to significant generic entry.
Long-Term (2025-2030)
- Generic market dominance forecasted, dropping prices to $300-$400 per 30-day supply.
- Additional biosimilar/drug combination products could influence pricing strategies.
- Market growth projected at 4% annually, driven by expanding indications and aging populations.
Market Entry and Competition Considerations
- Generics approvals are expected to accelerate post-patent expiration.
- Pricing will depend heavily on regulatory approvals, biosimilar landscape, and payer negotiations.
- New formulations or combination therapies could sustain premium pricing for specific patient subsets.
Conclusion
Empagliflozin (NDC 00088-2102) is positioned to experience substantial price decline after patent expiration, with generic entries potentially reducing costs by up to 50%. Market share improvements for competitors and expanded indications could influence future pricing. The drug's sales dominance is expected to diminish but remain relevant due to new indications and ongoing clinical use.
Key Takeaways
- Empagliflozin had $3.8 billion in global sales in 2022.
- Patent expiry expected between 2024 and 2026 will trigger significant price reductions.
- Prices are projected to decline by 20-30% for brand, and 50% or more for generics, by 2025-2026.
- Market share will shift as generics penetrate, balancing pricing strategies for pharma companies.
- Expanded indications could support sustained higher pricing for specific patient groups.
FAQs
1. When will generic versions of empagliflozin enter the market?
Patent expiration is expected between 2024 and 2026, depending on jurisdictional patent protections and legal considerations.
2. How will the entry of generics impact pricing?
Prices are anticipated to fall by approximately 50% or more for generics relative to brand-name prices due to increased competition.
3. What are the main indications for empagliflozin?
It is approved for type 2 diabetes, reducing cardiovascular mortality in adults with heart failure, and for diabetic kidney disease.
4. Are there upcoming regulatory approvals that could affect sales?
Yes. Label expansions for heart failure and kidney disease are likely to boost sales and market penetration.
5. How does pricing compare across key markets?
In the U.S., retail prices for branded formulations are around $550/month, with discounts due to rebates. European markets generally have lower prices, around €400-€500 ($460-$575), depending on local regulations, with prices dropping further for generics.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] EvaluatePharma. (2023). World Preview 2023.
[3] U.S. Food and Drug Administration. (2022). Empagliflozin FDA Approval Announcements.
[4] European Medicines Agency. (2023). Label Expansion for Empagliflozin.
[5] Medicare Pricing Data. (2023). Medication Price Trends.
