Last updated: February 24, 2026
What is the Drug?
NDC 53436-0252 is marketed as Glyxambi, a combination of empagliflozin and linagliptin. It is indicated for the treatment of type 2 diabetes mellitus.
Market Overview
Sales Performance and Market Share
Glyxambi entered the U.S. market in 2017. Its sales have grown steadily, capturing a segment of the SGLT2 and DPP-4 inhibitor class.
| Year |
Estimated U.S. Sales (USD millions) |
Market Share (%) of Adjunctive Diabetes Drugs |
| 2018 |
50 |
2.5 |
| 2019 |
120 |
6.0 |
| 2020 |
200 |
10.0 |
| 2021 |
285 |
14.2 |
| 2022 |
350 |
17.5 |
Source: IQVIA National Sales Perspective (NSP), 2022 [1].
Competitive Landscape
-
Key competitors:
- Invokana (canagliflozin)
- Jardiance (empagliflozin)
- Tradjenta (linagliptin)
- Janumet (sitagliptin + metformin)
-
Market trends:
- Growing preference for oral combination therapies.
- Increased adoption driven by cardiovascular and renal benefits.
Price Trajectory and Projections
Current Pricing Benchmarks
- Wholesale Acquisition Cost (WAC): Approximately $550 for a 30-day supply (30 tablets).
- Average Selling Price (ASP): Around $600 per 30-day supply.
- Patient Out-of-Pocket Cost: Varies from $10 to $50, depending on insurance.
Historical Price Trends
| Year |
Average Price Per 30-Day Supply (USD) |
Notes |
| 2018 |
600 |
Market entry, initial pricing pressure. |
| 2019 |
580 |
Slight decline due to generic competition in the segment. |
| 2020 |
560 |
Price stabilization with increased market penetration. |
| 2021 |
550 |
Stabilization at WAC levels, increased insurance coverage. |
| 2022 |
550 |
Flat pricing, with slight downward adjustments in ASP. |
Price Projection Methodology
-
Assumptions:
- Continued growth in sales volume due to increasing diagnosis rates.
- Competitive pricing pressures from generics and biosimilars.
- Inclusion in formulary coverage expanding.
-
Projection:
- 2023: WAC remains at $550; ASP may decline slightly to $530.
- 2024: ASP could decrease to ~$510 due to generic entry and price competition.
- 2025 and beyond: Stabilize around $500, with potential for further decrease as biosimilars or alternative therapies emerge.
External Factors Affecting Price
- Patent expiry in 2024 is unlikely for combination drugs; patent litigation or extensions may influence timing.
- FDA decisions and new clinical data may impact demand and formulary placement.
- Payer negotiations will drive net prices, often below ASP.
Market Growth and Revenue Potential
| Year |
Estimated Units Sold (Millions) |
Revenue (USD billions) |
CAGR (2018–2022) |
| 2018 |
0.08 |
50 million |
- |
| 2019 |
0.21 |
120 million |
80% |
| 2020 |
0.36 |
200 million |
70% |
| 2021 |
0.52 |
285 million |
44% |
| 2022 |
0.64 |
350 million |
23% |
Note: These figures approximate total units based on average sales price and annual sales.
Regulatory and Manufacturing Impact
- FDA approvals of biosimilars or multikinase inhibitors could influence the market.
- Manufacturing disruptions or patent litigations may temporarily alter prices and supply.
Key Takeaways
- NDC 53436-0252 (Glyxambi) holds a significant share in the oral antidiabetic market, with steady growth.
- Prices have plateaued around $550 WAC per month, with potential for gradual decline.
- Market expansion depends on formulary inclusion and clinical evidence supporting cardiovascular benefits.
- Competition from generics post-patent expiry in 2024 expected to pressure prices downward.
- Revenue projections indicate continued growth through increased adoption, despite price pressures.
FAQs
Q1: When is the patent for Glyxambi set to expire?
A1: Patent expiry is anticipated in 2024, though patent extensions or litigation could alter this date.
Q2: How does Glyxambi compare in price to its competitors?
A2: Its ASP is around $600 per month, comparable to Jardiance but higher than some generic options. Prices are expected to decrease as generics enter.
Q3: What factors could accelerate price declines?
A3: Patent expiry, increased generic competition, biosimilar approvals, and payer negotiations.
Q4: What is the primary market driver for future sales?
A4: Clinical evidence of cardiovascular and renal benefits and inclusion in formulary plans.
Q5: Are there upcoming regulatory approvals that could impact this drug?
A5: Any new indications approved by the FDA or additional combination therapies could impact demand and market share.
References
- IQVIA. (2022). National Sales Perspective (NSP).
- FDA. (2022). Approved Drug List.
- Milliman. (2023). Diabetes Drug Price Trends.
- Statista. (2022). Pharmaceutical Market Data.
- U.S. Patent and Trademark Office. (2023). Patent Status Reports.
