Last updated: February 24, 2026
What is NDC 33342-0554?
NDC 33342-0554 is the National Drug Code identifier for Glyxambi (empagliflozin and linagliptin), a combination medication used to treat type 2 diabetes mellitus. It combines an SGLT2 inhibitor with a DPP-4 inhibitor, approved by the FDA in November 2017.
Market Overview
Therapeutic Class and Competitive Landscape
Glyxambi targets the diabetes segment, competing primarily with other combination and monotherapy drugs such as:
- Trulicity (dulaglutide)
- Jardiance (empagliflozin)
- Janumet (sitagliptin/metformin)
- Farxiga (dapagliflozin)
The global diabetes drug market exceeded USD 70 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5% through 2030. The segment benefits from increasing prevalence (over 400 million people worldwide) and a rising shift toward combination therapies.
Market Position
Glyxambi’s lineage of SGLT2/DPP-4 combos has maintained a niche position. Empagliflozin (from AstraZeneca) has established a leading market share for SGLT2 inhibitors, whereas linagliptin (from Boehringer Ingelheim) holds solid positioning among DPP-4 inhibitors.
Sales Data
In 2022, Glyxambi’s US retail sales were approximately USD 300 million, placing it behind top competitors such as Jardiance and Janumet. The drug's sales growth has plateaued, influenced by pricing pressures and market penetration challenges.
Pricing Dynamics
Current Price Points
- Wholesale acquisition costs (WAC): Approximately USD 600-700 per month (30-day supply).
- Average retail price: USD 650 per month, with variations based on pharmacy benefit manager (PBM) negotiations and insurance coverage.
Reimbursement Considerations
Insurance coverage heavily influences patient out-of-pocket expenses. Co-pays typically range from USD 20-50 for branded drugs, depending on insurance tier. Generic or biosimilar alternatives are absent, maintaining high pricing.
Price Comparisons
| Drug |
Formulation |
Monthly Cost (USD) |
Market Share (2022) |
| Glyxambi |
10 mg/5 mg (empagliflozin/linagliptin) |
650 |
0.4% (of diabetes market) |
| Jardiance |
10 mg (empagliflozin) |
600 |
4% |
| Janumet |
50/500 mg (sitagliptin/metformin) |
500 |
3% |
Price Trends
Glyxambi prices have remained relatively stable since market entry in 2017. Price erosion is limited compared to older monotherapies due to lack of biosimilars and patent exclusivity.
Market Forecasts
Short-term Projections (2023–2025)
- Growth driven by increased adoption for combination therapy in early-stage T2DM treatment.
- Sales to reach approximately USD 400 million by 2025, assuming a 10-15% annual growth rate driven by formulary expansion.
Long-term Outlook (2026–2030)
- Market penetration expected to plateau unless new indications or formulations emerge.
- Possible stabilization or decline in sales due to patent cliffs approximately in 2028 and emerging biosimilar competition, though this remains unlikely given current patent protections.
Price Projections (2023–2030)
| Year |
Expected Monthly Price (USD) |
Rationale |
| 2023 |
650 |
Market stability, no biosimilar competition |
| 2025 |
620–650 |
Slight reduction due to payer negotiations |
| 2028 |
600–630 |
Patent expiry approaches, biosimilar threat unlikely at this stage |
| 2030 |
600 |
Stabilization, contingent on regulatory and patent status |
Regulatory and Patent Outlook
Patent protections for Glyxambi are set to expire around 2028, opening opportunities for biosimilar entries. However, current patent litigation and exclusivity rights may delay biosimilar market entry until 2030.
Conclusions
Glyxambi remains a niche but stable segment of the diabetes market, with pricing well-supported by patent protections and brand loyalty. Market growth will be modest unless new formulations or indications are approved.
Key Takeaways
- Glyxambi’s US retail sales totaled approximately USD 300 million in 2022.
- Current prices hover around USD 650 per month with minimal downward pressure.
- The drug's sales are expected to grow modestly to USD 400 million by 2025, plateauing thereafter due to patent expiry and biosimilar competition.
- Pricing will likely remain stable through 2030, barring regulatory or legal changes.
FAQs
Q1: How will patent expiration affect Glyxambi’s pricing?
Patent expiry around 2028 could introduce biosimilars, leading to price reductions of up to 30-50%, depending on market competition.
Q2: What clinical factors influence Glyxambi’s market share?
Efficacy, safety profile, and contraindications shape prescription patterns, with newer SGLT2 inhibitors and GLP-1 receptor agonists increasingly favored.
Q3: How does insurance coverage impact the drug’s market?
High out-of-pocket costs limit patient access, but formulary inclusion mitigates this effect via preferred positioning and co-pay support.
Q4: Are there regulatory changes that could impact prices?
Potential patent challenges and biosimilar approvals may influence future pricing and market dynamics.
Q5: What new developments could disrupt current projections?
Emergence of next-generation combination therapies, updates to clinical guidelines favoring other classes, or regulatory delays could alter market trajectories.
References:
[1] IQVIA. (2023). Pharmaceutical Market Reports.
[2] U.S. Food and Drug Administration. (2017). Glyxambi NDA Approval.
[3] EvaluatePharma. (2023). Global Diabetes Market Data.
[4] FDA. (2022). Patent and Exclusivity Data.
[5] Medicare & Medicaid Services. (2023). Drug Pricing and Reimbursement Data.
Note: Certain figures are estimates based on publicly available market reports and pricing data as of early 2023.
