Last updated: February 15, 2026
What Is the Market Status of Drug NDC: 00597-0109?
The drug under NDC 00597-0109 is Empagliflozin, marketed as Jardiance by Boehringer Ingelheim. It is approved for treating type 2 diabetes mellitus, with indications expanding to heart failure and chronic kidney disease. The drug is part of the SGLT2 inhibitor class, which influences renal glucose reabsorption.
Market penetration for Empagliflozin remains robust, primarily driven by its therapeutic versatility and recent label enhancements. Key competitors include drugs like Glucophage (metformin), Jardiance's close competitors such as Invokana (canagliflozin), and newer SGLT2 inhibitors with emerging indications.
How Does the Current Market Landscape Look?
Revenue and Sales Trends
- In 2022, Jardiance generated approximately $4.2 billion globally, a compound annual growth rate (CAGR) surpassing 20% from 2019 to 2022 [1].
- U.S. sales accounted for around 70% of this revenue, reflective of high penetration in the American market.
- Sales growth slowed in late 2022 due to increased competition, patent litigations, and market saturation, but remains positive.
Market Share
- Estimated market share for Jardiance in the oral SGLT2 inhibitor segment was approximately 31% in 2022, trailing Invokana at 34%, but ahead of Farxiga (dapagliflozin) at 22% [2].
- The SGLT2 class's share in the U.S. diabetes market exceeded 15% in volume terms.
Market Drivers and Barriers
Drivers:
- Proven cardiovascular and renal benefits.
- Expanded approvals covering heart failure and kidney protection.
- Physician preference for drugs with proven additional benefits.
Barriers:
- Cost: Typical annual treatment costs range from $6,000 to $7,000 before insurance.
- Adverse effects: Increased risk of genital infections, ketoacidosis.
- Competition: Introduction of biosimilars and new molecular entities.
What Are the Price Projections for NDC 00597-0109?
Current Pricing Dynamics
- The average wholesale price (AWP) for Jardiance in the U.S. is approximately $595 per month per prescription, equating to roughly $7,140 annually [3].
- With insurance coverage, patients often face copays between $10 and $50 monthly, depending on plan formulary positioning.
Forecasted Price Trends
- Short-term (next 1–2 years): Stable prices with minor fluctuations driven by inflation, market share shifts, and pharmacy benefit manager (PBM) negotiations.
- Mid-term (3–5 years): Prices may decline by 10–15% if biosimilar or alternative therapies gain market traction or if payer negotiations intensify.
- Long-term (5+ years): Price reductions might accelerate due to patent expirations, biosimilar emergence, and regulatory pressure for cost containment.
Factors Affecting Price Projections
- Patent Status: Patents on Jardiance expire in the U.S. in 2030 [4], opening potential for biosimilar competition.
- Regulatory Policies: Efforts to control drug costs may lead to price caps or negotiation leverage by Medicare and private payers.
- Market Acceptance: Increased indication approvals for heart failure and CKD could sustain or elevate demand, supporting stable pricing.
How Do These Projections Compare with Similar Drugs?
| Drug Name |
Indication |
2022 U.S. Sales |
Approximate Monthly Price |
Patent Expiry |
Market Share (2022) |
| Jardiance (00597-0109) |
Diabetes, HF, CKD |
$2.94B |
$595 |
2030 |
31% (SGLT2 class) |
| Invokana |
Diabetes |
$1.66B |
$585 |
2022* |
34% (SGLT2 class) |
| Farxiga |
Diabetes, HF, CKD |
$2.50B |
$570 |
2025 |
22% (SGLT2 class) |
*Note: Invokana patent protections expired in 2022, leading to biosimilar entry.
Key Takeaways
- Empagliflozin (NDC 00597-0109) held approximately 31% of the U.S. SGLT2 inhibitor market in 2022.
- Sales revenue reached over $4.2 billion globally in 2022, with a consistent growth pattern.
- Prices currently hover around $595/month, with foreseeable declines of up to 15% over the next five years due to patent expirations and competitive pressures.
- The expiration of key patents by 2030 and increasing indications extend the drug’s commercial relevance.
- Market drivers include proven cardiovascular and renal benefits, while barriers include cost and safety concerns.
FAQs
1. When will generic versions of Jardiance likely enter the market?
Patent expiration in the U.S. is expected in 2030, opening opportunities for biosimilar or generic competition soon after.
2. How are regulatory changes affecting prices?
Policy initiatives aimed at drug cost control, including negotiations by Medicare, could pressure prices downward beyond organic market trends.
3. What markets outside the U.S. are significant for Jardiance?
European markets, especially Germany and the UK, account for significant sales, but pricing and reimbursement policies vary widely.
4. Are there upcoming indications that could boost Jardiance's market?
Yes, ongoing studies for heart failure and chronic kidney disease could expand its use and sustain revenue streams.
5. How does the competitive landscape impact future sales?
The introduction of biosimilars post-2030 and development of next-generation SGLT2 inhibitors present both threats and opportunities for market share shifts.
References
- IQVIA, 2022. "Pharmaceutical Sales Data."
- Evaluate Pharma, 2022. "Global Sales and Market Share Analysis."
- GoodRx, 2023. "Drug Price Comparison."
- FDA, 2022. "Patent Expiry and Market Exclusivity for Jardiance."
