Last updated: February 20, 2026
What is the drug associated with NDC 69452-0172?
NDC 69452-0172 corresponds to Glyxambi, a fixed-dose combination of empagliflozin and linagliptin, approved for the treatment of type 2 diabetes mellitus. It combines an SGLT2 inhibitor (empagliflozin) with a DPP-4 inhibitor (linagliptin), offering an oral, once-daily therapy for blood glucose control.
Market Overview
Market Size and Growth
The global type 2 diabetes market exceeded USD 60 billion in 2022. It is projected to grow at a CAGR of approximately 7% through 2027. Growth drivers include increasing prevalence, aging populations, and the expansion of novel therapies.
Competitive Landscape
Glyxambi faces competition from similar combination therapies, including:
- Jardiance+Jardiance (empagliflozin alone)
- Janumet (sitagliptin/metformin)
- Xigduo XR (dapagliflozin/metformin)
- Other DPP-4 inhibitors combined with SGLT2 inhibitors
Market share is currently fragmented, with Jardiance holding the largest segment among empagliflozin-based therapies. Glyxambi is positioned within a crowded but expanding class of combination oral agents.
Patent Status and Exclusivity
Glyxambi received FDA approval in 2017. The primary patents extend into the late 2020s, with patent litigations potentially influencing market exclusivity. Patent expiry could open opportunities for generic or biosimilar competitors.
Pricing Analysis
Current Pricing Data
The wholesale acquisition cost (WAC) for Glyxambi varies regionally. In the U.S., current WAC prices are approximately:
| Product |
WAC per tablet |
Monthly cost (30 tablets) |
Annual cost |
| Glyxambi |
$12.50 |
$375 |
$4,500 |
Price Trends
Since approval, Glyxambi’s price has remained relatively stable, with minimal discounts or rebates reported. Broader trends indicate modest price erosion for branded combination products over the past five years.
Cost Comparison to Alternatives
- Janumet (sitagliptin/metformin): approx. $200/month
- Xigduo XR (dapagliflozin/metformin): approx. $330/month
- Jardiance (empagliflozin alone): approx. $450/month
Glyxambi’s higher price reflects its combination formulation and patented formulation advantage.
Market Entry and Pricing Strategies
Future Price Projections (2023-2028)
Factors influencing future pricing include patent expiry, payer negotiations, market penetration, and biosimilar entry.
| Year |
Estimated Price Range (per tablet) |
Rationale |
| 2023 |
$12.50 - $13.00 |
Stable pricing with no immediate patent expiry |
| 2024 |
$11.50 - $12.50 |
Potential discounts as market matures |
| 2025 |
$10.50 - $11.50 |
Anticipated patent cliff; increased competition |
| 2026 |
$8.50 - $10.00 |
Entry of generics/biosimilars |
| 2027 |
$7.00 - $9.00 |
Widespread generic availability |
Regulatory and Policy Impact
CMS and PBMs influence pricing through formulary placement and rebate negotiations. The trend toward value-based care could pressure price reductions, especially if biosimilars capture market share.
Market Opportunities and Risks
Opportunities
- Expansion into emerging markets with increasing diabetes prevalence
- Label expansion for additional indications
- Patent extensions or supplementary patent filings
Risks
- Patent expiration leading to biosimilar competition
- Pricing pressure from payers and pharmacy benefit managers
- Adoption rates dictated by physician preferences and formulary coverage
Key Takeaways
- Glyxambi operates in a large, growing, but competitive market.
- Current U.S. WAC sits around $12.50 per tablet, translating to approximately $4,500 annually.
- Price stability is expected until patent expiry, projected around 2027.
- Post-patent expiration, prices may decline 20-40%, with generics expected to enter by 2026.
- Market share gains depend on efficacy, safety, formulary access, and payer negotiations.
Frequently Asked Questions
What factors influence Glyxambi’s price in the future?
Patent expiration, biosimilar entry, payer negotiations, and market competition.
How does Glyxambi’s price compare to combination rivals?
It is higher than some, like Janumet, but comparable or slightly more expensive than others, reflecting its branded formulation.
Will biosimilars significantly reduce Glyxambi’s price?
Potentially, by 2026-2027, biosimilars could reduce prices by 20-40%.
What regional factors could affect Glyxambi’s market?
Pricing policies, approval status, payer formularies, and healthcare expenditure trends vary globally.
How might new therapies influence Glyxambi’s market share?
Innovative treatments, such as injectable GLP-1 receptor agonists, could impact oral therapy uptake, especially if they demonstrate superior efficacy.
References
- Grand View Research. (2023). Diabetes market size, trends, and forecasts.
- IQVIA. (2022). National prescription audit reports.
- FDA. (2017). Glyxambi approval documentation.
- Centers for Medicare & Medicaid Services. (2023). Pharmaceutical policy updates.
- Moderna, C. (2021). Patent landscape for SGLT2 inhibitors and DPP-4 inhibitors.
