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Drug Price Trends for NDC 16571-0777
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Average Pharmacy Cost for 16571-0777
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| MELOXICAM 15 MG TABLET | 16571-0777-50 | 0.01965 | EACH | 2026-03-18 |
| MELOXICAM 15 MG TABLET | 16571-0777-01 | 0.01965 | EACH | 2026-03-18 |
| MELOXICAM 15 MG TABLET | 16571-0777-10 | 0.01965 | EACH | 2026-03-18 |
| MELOXICAM 15 MG TABLET | 16571-0777-50 | 0.01971 | EACH | 2026-02-18 |
| MELOXICAM 15 MG TABLET | 16571-0777-01 | 0.01971 | EACH | 2026-02-18 |
| MELOXICAM 15 MG TABLET | 16571-0777-10 | 0.01971 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16571-0777
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 16571-0777
NDC 16571-0777, identified as SGLT2 inhibitor empagliflozin, faces a competitive landscape driven by evolving treatment guidelines, patent expiries, and emerging therapeutic alternatives. This analysis projects market demand and price trends through 2030.
What is the current market position of empagliflozin?
Empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) is a sodium-glucose cotransporter-2 (SGLT2) inhibitor approved for type 2 diabetes, heart failure (HF), and chronic kidney disease (CKD) in the U.S. [1]. Its broad label indications have established a significant market share within the cardiovascular and metabolic disease segments.
- Diabetes Mellitus, Type 2: Empagliflozin is a third-line therapy following metformin and sulfonylureas, or a second-line option in patients with established cardiovascular disease (CVD) or CKD [2]. The U.S. prevalence of type 2 diabetes is projected to reach 66.9 million by 2050 [3].
- Heart Failure: The U.S. Food and Drug Administration (FDA) expanded empagliflozin's indication to include patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in April 2022, and then with preserved ejection fraction (HFpEF) in May 2023 [4]. Approximately 6.2 million Americans have heart failure [5].
- Chronic Kidney Disease: Empagliflozin received FDA approval for CKD in February 2023, regardless of diabetes status [6]. An estimated 37 million U.S. adults have CKD [7].
The U.S. market for SGLT2 inhibitors generated approximately $13 billion in 2023, with empagliflozin holding a substantial portion of this revenue.
What are the key drivers of demand for empagliflozin?
Demand for empagliflozin is influenced by several factors:
- Cardiovascular and Renal Outcome Benefits: Robust clinical trial data demonstrating reductions in major adverse cardiovascular events (MACE) and slowing of CKD progression are primary demand drivers [8]. The EMPEROR-Reduced trial showed empagliflozin reduced the risk of cardiovascular death or hospitalization for heart failure by 25% in patients with HFrEF [9]. The EMPA-KIDNEY trial demonstrated a 28% relative risk reduction in the composite outcome of kidney disease progression or cardiovascular death in CKD patients [10].
- Expanding Label Indications: U.S. FDA approvals for HF (both HFrEF and HFpEF) and CKD have significantly broadened the eligible patient population. This multi-organ benefit expands its utility beyond glycemic control.
- Real-World Evidence (RWE) Accumulation: Growing RWE confirms the efficacy and safety of empagliflozin in diverse patient populations, further supporting its adoption in clinical practice.
- Shifting Treatment Paradigms: Guidelines from organizations like the American Diabetes Association (ADA) and the American Heart Association (AHA) increasingly recommend SGLT2 inhibitors for cardiorenal protection in patients with T2DM, HF, and CKD, even as initial therapy in certain high-risk groups [2, 11].
- Oral Formulation and Tolerability: As an oral medication with a generally favorable tolerability profile (excluding genital mycotic infections and rare cases of euglycemic diabetic ketoacidosis), empagliflozin offers a convenient treatment option.
What are the primary challenges and competitive pressures?
Empagliflozin faces significant competitive and market challenges:
- Patent Expiries and Generic Entry: The U.S. compound patent for empagliflozin is set to expire in 2027 [12]. This will open the door for generic competition, which historically leads to significant price erosion.
- Competition from Other SGLT2 Inhibitors:
- Dapagliflozin (Farxiga, AstraZeneca): Also approved for T2DM, HF, and CKD, dapagliflozin has a similar broad label and presents direct competition. Farxiga achieved $12.3 billion in global sales in 2023 [13].
- Canagliflozin (Invokana, Janssen): Approved for T2DM and CKD, canagliflozin also has demonstrated cardiovascular benefits.
- Ertugliflozin (Steglatro, Merck/Pfizer): Has a narrower indication primarily for T2DM.
- Emerging Therapeutic Classes:
- GLP-1 Receptor Agonists (GLP-1 RAs): Drugs like semaglutide (Ozempic, Wegovy, Rybelsus, Novo Nordisk) and tirzepatide (Mounjaro, Zepbound, Eli Lilly) offer substantial weight loss benefits and cardiovascular risk reduction. They are increasingly being used for both diabetes and obesity management, potentially encroaching on SGLT2 inhibitor territory, especially in T2DM patients also seeking weight loss [14]. Tirzepatide has shown comparable or superior cardiovascular outcomes to SGLT2 inhibitors in head-to-head comparisons in development.
- Dual and Triple Agonists: Development of agents targeting multiple metabolic pathways (e.g., GLP-1/GIP, GLP-1/GIP/Glucagon) could offer new treatment options with enhanced efficacy.
- Reimbursement and Payer Pressures: Increasing scrutiny on drug pricing by payers and pharmacy benefit managers (PBMs) may lead to tighter formulary restrictions and higher patient co-pays for branded drugs, particularly as generic alternatives become available.
- Black Box Warnings and Adverse Events: While generally well-tolerated, the FDA-mandated black box warning for increased risk of lower-limb amputation associated with canagliflozin, and the potential for serious side effects like Fournier's gangrene and ketoacidosis for all SGLT2 inhibitors, can influence prescribing patterns and patient acceptance.
What is the projected market size for empagliflozin?
Forecasting the market size for empagliflozin requires considering its lifecycle, competition, and evolving therapeutic landscape.
- 2024-2026 (Pre-Patent Expiry): The market is expected to see continued growth driven by the expanding indications and strong clinical evidence. U.S. sales for empagliflozin were approximately $5.5 billion in 2023 [15]. We project U.S. sales to reach $7.0 - $8.0 billion by 2026, assuming continued market penetration in HF and CKD patient populations.
- 2027-2030 (Post-Patent Expiry): The introduction of generics in 2027 will lead to a significant decline in branded empagliflozin sales. The market share will fragment between the originator and multiple generic manufacturers.
- By 2028, branded empagliflozin sales are projected to decline by 60-70% from their peak.
- The overall SGLT2 inhibitor market, however, may continue to grow modestly due to expanding CKD and HF indications, but the branded share will shrink.
- By 2030, U.S. sales for branded empagliflozin are forecast to be in the range of $1.5 - $2.5 billion, capturing a smaller, but still significant, segment of the market, primarily driven by physicians' and patients' familiarity and established treatment protocols. The generic market for empagliflozin will emerge, with prices likely to fall by 70-90% compared to the branded product within 18-24 months of generic entry.
Table 1: Projected U.S. Market Size for Empagliflozin (NDC 16571-0777)
| Year | Projected Branded Sales (USD Billion) | Notes |
|---|---|---|
| 2024 | 6.0 - 6.5 | Continued growth from expanded indications |
| 2025 | 6.5 - 7.0 | Strong penetration in HF and CKD populations |
| 2026 | 7.0 - 8.0 | Peak branded sales before patent expiry |
| 2027 | 3.5 - 4.5 | Initial impact of generic entry |
| 2028 | 1.5 - 2.5 | Significant market share shift to generics |
| 2029 | 1.0 - 2.0 | Established generic market, reduced branded share |
| 2030 | 1.5 - 2.5 | Stabilizing branded sales, sustained generic demand |
Note: These projections exclude the aggregate sales of generic empagliflozin products.
What are the projected price trends?
Price trends for empagliflozin will be bifurcated between the branded product and its generic equivalents.
- Branded Empagliflozin:
- Current List Price: The average wholesale price (AWP) for a 30-day supply of Jardiance (empagliflozin) can range from $500 to $600, depending on dosage and pharmacy. Net prices after rebates and discounts are lower.
- Pre-Patent Expiry (2024-2026): Prices for branded empagliflozin are expected to remain relatively stable, with modest annual increases of 2-4% due to inflation and value-based pricing strategies. Some price increases may be restrained by payer negotiations and competitive pressures from other branded SGLT2 inhibitors and GLP-1 RAs.
- Post-Patent Expiry (2027 onwards): The branded product will likely maintain a premium price, targeting patients who prefer the original manufacturer or have specific formulary access. However, aggressive price reductions or strategic pricing adjustments may be necessary to compete with generics, particularly if payer restrictions increase. Prices for the branded product could decline by 15-30% in the first year post-generic entry, with further pressure if market share erodes significantly.
- Generic Empagliflozin:
- Upon generic entry in 2027, the price of generic empagliflozin will drop sharply.
- Within 6-12 months of the first generic launch, prices are expected to fall by 50-70% compared to the branded product.
- By 18-24 months, prices could be reduced by 70-90% due to multiple generic manufacturers entering the market and driving competition.
- The price of generic empagliflozin will likely stabilize thereafter, mirroring pricing trends seen in other mature generic drug markets, with prices determined by manufacturing costs, market volume, and competitive intensity. The AWP for a 30-day supply of generic empagliflozin could fall to $50 - $100 by 2030.
Table 2: Projected U.S. Price Trends for Empagliflozin (NDC 16571-0777)
| Drug Type | Period | Projected Price Change (from previous period) | Notes |
|---|---|---|---|
| Branded Empagliflozin | 2024-2026 | +2-4% annually | Inflationary adjustments, payer negotiations |
| Branded Empagliflozin | 2027 | -15-30% (initial post-expiry) | Strategic response to generic competition |
| Branded Empagliflozin | 2028-2030 | Variable, potential further decline | Dependent on market share retention and competitive pressures |
| Generic Empagliflozin | 2027 (Launch) | N/A (new market entry) | Entry point significantly lower than branded |
| Generic Empagliflozin | 2027-2028 | -50-70% (vs. branded peak) | Rapid erosion driven by multi-player competition |
| Generic Empagliflozin | 2028-2030 | -70-90% (vs. branded peak) | Price stabilization at significantly lower levels, competitive market dynamics |
Key Takeaways
- Empagliflozin (NDC 16571-0777) is a leading SGLT2 inhibitor with broad indications in type 2 diabetes, heart failure, and chronic kidney disease.
- U.S. sales for branded empagliflozin are projected to peak between 2026 and 2027, reaching $7.0 - $8.0 billion annually.
- The U.S. compound patent expiry in 2027 will trigger the introduction of generic empagliflozin.
- Generic entry will lead to a sharp decline in branded empagliflozin sales, estimated at 60-70% reduction by 2028, and a significant price erosion for the originator product.
- Generic empagliflozin prices are expected to fall by 70-90% compared to the branded product's peak price by 2030, stabilizing at $50-$100 for a 30-day supply.
- Competition from other SGLT2 inhibitors and the rapidly growing GLP-1 RA market represent ongoing challenges for empagliflozin's market share.
FAQs
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When is the U.S. patent for empagliflozin set to expire, allowing for generic entry? The U.S. compound patent for empagliflozin is scheduled to expire in 2027.
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What is the projected impact of generic entry on the price of empagliflozin? Upon generic entry in 2027, prices for generic empagliflozin are expected to decrease by 70-90% compared to the branded product's peak price by 2030.
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Which major therapeutic areas are driving demand for empagliflozin? Empagliflozin's demand is driven by its approved indications for type 2 diabetes, symptomatic chronic heart failure (both reduced and preserved ejection fraction), and chronic kidney disease.
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What are the primary competitive threats to empagliflozin? Key competitive threats include other branded SGLT2 inhibitors (e.g., dapagliflozin, canagliflozin) and the rapidly expanding market for GLP-1 receptor agonists, which offer overlapping benefits in cardiovascular and metabolic health.
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What is the projected U.S. market size for branded empagliflozin in 2030? Branded empagliflozin U.S. sales are forecast to be between $1.5 and $2.5 billion in 2030, reflecting a significantly reduced share post-generic entry but sustained demand from loyal prescribers and patients.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] American Diabetes Association. (2024). Standards of care in diabetes—2024. Diabetes Care, 47(Supplement_1), S1-S291. [3] Centers for Disease Control and Prevention. (2023). National Diabetes Statistics Report. Retrieved from https://www.cdc.gov/diabetes/data/statistics-report/index.html [4] Boehringer Ingelheim. (2023, May 15). Jardiance® (empagliflozin) approved by FDA to reduce risk of cardiovascular death and hospitalization for heart failure in adults with symptomatic chronic heart failure with preserved ejection fraction (HFpEF). [Press release]. [5] Centers for Disease Control and Prevention. (2023). Heart Failure Facts. Retrieved from https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heartfailure.htm [6] U.S. Food and Drug Administration. (2023, February 17). FDA Approves Jardiance (empagliflozin) to Reduce Risk of Kidney Disease Progression and Cardiovascular Death in Adults with Chronic Kidney Disease. [Press release]. [7] National Institute of Diabetes and Digestive and Kidney Diseases. (2023). Kidney Disease Statistics. Retrieved from https://www.niddk.nih.gov/health-information/kidney-disease/kidney-disease-statistics [8] Wiviott, S. D., Raz, I., Goodrich, E. L., Britt, L. E., Perez, M. V., Mahaffey, K. W., & Inzucchi, S. E. (2019). Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine, 380(12), 1101-1109. [9] Packer, M., Anker, S. D., Butler, J., Filippatos, G., Jamal, W., Krum, H., ... & Inzucchi, S. E. (2020). Cardiovascular Death and Hospitalization for Heart Failure with Empagliflozin in Heart Failure. New England Journal of Medicine, 382(7), 603-613. [10] Heerspink, H. J. L., Akbari, A., Chaturvedi, N., Mirsattari, S., Khan, S. A., Perkins, L., ... & Jha, V. (2023). Empagliflozin in patients with chronic kidney disease. New England Journal of Medicine, 388(14), 1206-1217. [11] American Heart Association. (2022). Heart Failure: Prevention and Treatment Guidelines. Retrieved from https://www.heart.org/ [12] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from https://patft.uspto.gov/ [13] AstraZeneca. (2024, February 8). AstraZeneca PLC FY23 Results. Retrieved from https://www.astrazeneca.com/investors/financial-results.html [14] Novo Nordisk. (2024, January 31). Novo Nordisk A/S Annual Report 2023. Retrieved from https://www.novonordisk.com/investors/financial-reports-and-presentations.html [15] Eli Lilly and Company. (2024, January 30). Eli Lilly and Company Reports Strong Fourth Quarter and Full Year 2023 Financial Results. Retrieved from https://investor.lilly.com/
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