Last updated: February 17, 2026
What is the drug associated with NDC 62559-0758?
The National Drug Code (NDC) 62559-0758 refers to Glyxambi, a fixed-dose combination of empagliflozin and linagliptin. It is indicated for managing type 2 diabetes mellitus.
Market Size and Segmentation
Global prevalence:
Approximately 537 million adults globally had diabetes in 2021. The United States accounts for about 34 million diagnosed cases. The diabetic medications market, tailored largely towards type 2 diabetes, was valued at $70 billion in 2022.
Market segments:
- Insulin: Holds the largest share; over 60% of total diabetes medication revenue.
- Oral antidiabetics: Including SGLT2 inhibitors like empagliflozin, DPP-4 inhibitors like linagliptin. Represent over 35% of the market.
- Fixed-dose combinations: Increasing due to convenience and adherence benefits. Glyxambi has been promoted as a combination therapy for suboptimal control with monotherapy.
Competitive landscape:
Glyxambi faces competition primarily from other combination drugs, such as
- Dapagliflozin with saxagliptin (Qtern)
- Sitagliptin with ertugliflozin (Steglujan),
- Standalone drugs like Jardiance, Trulicity, and Invokana.
Key Market Drivers
- Rising diabetes prevalence: Accelerates demand.
- Shift towards combination therapies: Simplifies treatment and enhances compliance.
- Expanding clinical guidelines: Encourage early use of multiple agents for better glycemic control.
- Increased healthcare access: Especially in emerging markets, boosts drug uptake.
Regulatory Status and Pricing Trends
FDA Approval:
Glyxambi was approved in July 2017 for adults with type 2 diabetes. The approval expanded geographic use with other regulatory authorities, including EMA.
Pricing trends:
- United States (retail):
- Wholesale acquisition cost (WAC): Approximately $650 - $700 per month for a standard supply (30-day).
- Patient out-of-pocket (OOP): Typically $45 - $80 after insurance, depending on the plan.
- Europe: Prices vary between €40 - €100 per month.
Historical price dynamics:
Initial launch prices ranged from $650 to $750. Prices have remained stable, with minor reductions linked to generic or biosimilar entry planned post-patent expiration.
Patent Status and Impact on Pricing
Key patent dates:
- Original patents expired in the U.S. in 2023.
- Patent protections for Linagliptin end in 2028 in the U.S., potentially enabling biosimilar or generic competition.
Impact:
Price erosion expected to commence post-patent expiry, with potential reductions of 30-50% over a 2-3 year period, assuming market entry and coverage estimates.
Price Projections (Next 5 years)
| Year |
Price Range (USD/month) |
Factors Influencing Price |
| 2023 |
$650 - $700 |
Patent expiration, generic entry possible |
| 2024 |
$550 - $650 |
Rising competition, increased biosimilar supply |
| 2025 |
$450 - $550 |
Market saturation, price negotiations |
| 2026 |
$400 - $500 |
Expanded biosimilar approvals |
| 2027 |
$350 - $450 |
Widespread generic availability |
Market Penetration and Adoption
- Current global sales are concentrated in North America and Europe, with emerging markets showing increased uptake.
- Adoption remains high, driven by the convenience of fixed-dose combination therapy and evolving clinical practice guidelines.
Key Takeaways
- Glyxambi targets an expanding market for oral combination therapies in type 2 diabetes.
- Pricing remains stable in the short term but is expected to decline as patent protections expire.
- Market growth driven by increasing prevalence, clinical guideline shifts, and patient preferences.
- Competitive pressure will intensify with biosimilar and generic entrants, impacting pricing and market share.
FAQs
1. What factors will most influence Glyxambi's pricing in the next five years?
Patent expiration, biosimilar/generic entry, reimbursement policies, and manufacturer pricing strategies.
2. How does Glyxambi compare to other combination therapies?
It offers the convenience of two oral agents with proven efficacy. Competition focuses on efficacy, safety, price, and formulary inclusion.
3. What is the outlook for market share?
Market share is expected to stabilize or slightly decline post-patent expiry, as biosimilars gain traction.
4. Are there significant regional differences in pricing?
Yes. U.S. prices are generally higher than in Europe or emerging markets, driven by healthcare system differences and pricing regulations.
5. Will new drugs impact Glyxambi’s position?
Yes. Newer therapies with superior efficacy or oral delivery advantages can shift market share.
Sources
- IQVIA: Global diabetes market analysis, 2022.
- FDA: Glyxambi approval details, 2017.
- Pharmacoeconomics: Post-patent price trends, 2022.
- European Medicines Agency: Market data, 2022.
- EvaluatePharma: Forecasting longevity and sales, 2023.[1]
