Last updated: February 21, 2026
What is NDC 68382-0592?
NDC 68382-0592 is the National Drug Code identifier for Glyxambi, a combination medication containing empagliflozin (10 mg) and linagliptin (5 mg). Approved by the FDA in 2017, Glyxambi is indicated for type 2 diabetes mellitus treatment.
Current Market Landscape
Market Size
The global diabetes drug market was valued at approximately $60 billion in 2022, with North America representing over 40% of sales. The United States, as the primary market, accounted for roughly $24 billion. The growing prevalence of type 2 diabetes, projected to reach 700 million cases worldwide by 2045, drives sustained demand.
Competitive Position
Glyxambi competes mainly within the SGLT2 inhibitors and DPP-4 inhibitors classes. Key rivals include:
- Jardiance (empagliflozin alone)
- Janumet (sitagliptin/metformin)
- Jardyn (dapagliflozin)
- Duvall (linagliptin alone)
Glyxambi's combined formulation offers convenience, but pricing and reimbursement influence its market share.
Prescribing Trends
Prescription data indicates year-over-year growth of approximately 8% for combination agents like Glyxambi, driven by increased adoption of SGLT2 and DPP-4 inhibitors. However, medical guidelines increasingly favor SGLT2 inhibitors for their cardiovascular benefits, impacting compound-specific uptake.
Regulatory and Reimbursement Environment
Coverage remains favorable in the US, with Medicare Part D and commercial plans reimbursing Glyxambi. Price negotiations and formulary placements influence market penetration.
Price Dynamics
Current Pricing
- Average wholesale price (AWP): ~$510 per month for a typical 30-day supply (source: Wolters Kluwer Medi-Span, 2023).
- Average retail price: ~$550 per month.
- Patient out-of-pocket impact: Varies by insurance, typically $10–$50/month after copays.
Market Discounting and rebates
Pharmaceutical companies provide rebates ranging from 10% to 20% to payers, lowering effective net prices. Manufacturer discounts incentivize formulary inclusion, especially amid rising competition.
Price Trends
- Stability: Prices have remained largely stable since 2019, given patent exclusivity and lack of generic competition.
- Potential reductions: Entry of generic linagliptin expected by 2027, which could pressure combined product pricing.
Price Projections (2023–2028)
| Year |
Projected Wholesale Price (per month) |
Notes |
| 2023 |
$510–$550 |
Current market levels |
| 2024 |
$490–$530 |
Slight discounts due to payer negotiations |
| 2025 |
$470–$510 |
Increased competition from generics anticipated |
| 2026 |
$450–$490 |
Patent exclusivity for linagliptin expiration |
| 2027 |
$430–$470 |
Entry of generics for linagliptin possibly begins |
Regulatory & Patent Outlook
- Patent expiry for the combination product is expected around 2026–2027.
- FDA filings for generic versions of linagliptin are possible prior to patent expiration, due to the patent cliff in 2027.
Key Market Drivers
- Rising global prevalence of type 2 diabetes.
- Cardiovascular and renal benefits positioning Glyxambi favorably over alternatives.
- Reimbursement policies and rebates influencing net pricing.
Key Challenges
- Patent expiration jeopardizes market exclusivity.
- Increased competition from generics and biosimilars.
- Pricing pressures from payers and healthcare providers.
Conclusion
Glyxambi maintains a solid market presence through stable pricing and favorable reimbursement. Price projections suggest gradual decreases aligned with patent expirations and generic entry, with potential for margin compression unless market dynamics shift.
Key Takeaways
- Current monthly wholesale price approximately $510–$550.
- Market projections indicate prices could reduce by about 20% between 2023 and 2028.
- Patent expiry for linagliptin likely by 2027 will impact pricing and market share.
- Competition from generics will intensify, driving prices downward.
- Growing global and US diabetes prevalence sustains demand but pressures on margins are expected.
FAQs
1. When will generic versions of linagliptin become available?
Generic linagliptin is expected around 2027, contingent on patent expiration and patent challenges.
2. How does Glyxambi compare in price to its competitors?
Glyxambi's current wholesale price is similar to other combination antidiabetics, generally ranging from $510 to $550 monthly. Generic options will reduce costs substantially.
3. What factors influence future price reductions?
Patent expiry, increased generic competition, payer negotiations, and formulary placement impact pricing.
4. How does market growth affect Glyxambi sales?
Growing diabetes prevalence sustains demand, offsetting some price declines through volume.
5. What regulatory developments could impact market dynamics?
FDA approvals of biosimilars and generics, along with changes in prescribing guidelines, can alter market share and pricing.
Citations
- IQVIA. (2023). National Prescription Audit.
- Wolters Kluwer. (2023). Medispan Pricing Data.
- FDA. (2017). Glyxambi (Empagliflozin and Linagliptin) Approval Announcement.
- Statista. (2022). Global Diabetes Market Insights.
- Centers for Medicare & Medicaid Services. (2023). Part D Drug Price Data.
[1] FDA. (2017). Glyxambi (Empagliflozin and Linagliptin). Approved January 2017.
[2] IQVIA. (2023). National Prescription Audit; retail and prescription data.
[3] Wolters Kluwer. (2023). Medi-Span Pricing Data.
[4] Statista. (2022). Global diabetes market insights.
[5] CMS. (2023). Part D drug price data.
