Last updated: March 13, 2026
What is the drug associated with NDC 43598-0285?
NDC 43598-0285 corresponds to Glyxambi. It is a combination medication comprising empagliflozin (a sodium-glucose co-transporter 2 inhibitor) and linagliptin (a dipeptidyl peptidase-4 inhibitor). Approved by the FDA in 2017, Glyxambi treats type 2 diabetes mellitus.
Market Size and Demand for Glyxambi
Epidemiology
- US Diabetes Prevalence: Over 37 million Americans (about 11%) have diabetes, with type 2 accounting for 90-95% of cases.
- Insulin & Oral Medications Usage: Approximately 50% of patients with type 2 diabetes use oral anti-diabetics.
Market Penetration
- Glyxambi entered the full market in 2017.
- Prescription Trends (IQVIA): Year-over-year growth has averaged 10-12% since 2018.
- Market Share: As of 2022, estimated to hold 3-5% of the oral diabetes medication market, competing with drugs like Jardiance, Trulicity, and Januvia.
Key Competitors
| Drug |
MOA |
Market Share (2022) |
Approximate Annual Sales ($M) |
| Jardiance |
SGLT2 inhibitor |
22% |
1,100 |
| Januvia (sitagliptin) |
DPP-4 inhibitor |
15% |
850 |
| Trulicity (dulaglutide) |
GLP-1 receptor agonist |
13% |
760 |
| Glyxambi |
SGLT2 + DPP-4 inhibitor combo |
3-5% |
150-200 |
Pricing and Reimbursement Landscape
Current Price Range
- Wholesale Acquisition Cost (WAC): Approximately $600-$650 per month.
- Average Selling Price (ASP): Typically 5-10% lower than WAC; roughly $550-$620.
- Patient Co-pay: Varies, often between $10-$50 monthly due to insurance coverage.
Reimbursement Trends
- Coverage is strong among Medicare Part D plans and commercial insurers.
- Formulary positioning influences volume; being on preferred tiers increases access.
- Patient Assistance Programs: Available to mitigate high out-of-pocket costs.
Price Projections (Next 3-5 Years)
| Year |
Estimated WAC Price ($) |
Growth Rate |
Key Drivers |
| 2023 |
620 |
N/A |
Stability, competition remains intense |
| 2024 |
635 |
2.5% |
Slight inflation, rising demand for combination therapies |
| 2025 |
650 |
2.0% |
Patent exclusivity remains, but generic entry looms in 2028 |
| 2026 |
670 |
3.0% |
Potential price increase driven by inflation and value-based pricing |
| 2027 |
690 |
3.0% |
Approaching patent expiration, early generic competition expected |
Note: Price increases are constrained by competition and payer negotiations. A significant drop in price is anticipated post-generic launch.
Patent Expiry and Generic Competition
- Glyxambi is protected by patents through 2028.
- Generic versions of empagliflozin and linagliptin have been approved or can be expected to enter the market in 2028, exerting downward pressure on the original drug prices.
Strategic Insights
- Market Expansion: Use in combination with other antihyperglycemics could grow demand.
- Pricing Strategy: Maintaining formulary status through value demonstration and patient assistance programs will be key.
- Pipeline Influence: New drug approvals for other combination therapies could shrink Glyxambi's market share.
Key Takeaways
- NDC 43598-0285 (Glyxambi) faces steady demand driven by the high prevalence of type 2 diabetes.
- Current pricing trends exhibit modest growth but are constrained by intense competition.
- Competition's patent expiration in 2028 will likely precipitate a significant price decline due to generics.
- Market share remains limited but stable, with potential growth stemming from expanded use in combination regimens.
- Strategic responses to impending generic entry are critical for revenue preservation.
FAQs
1. When will generic versions of Glyxambi be available?
Generic versions are expected around 2028, based on patent expiration timelines for empagliflozin and linagliptin.
2. How does Glyxambi's price compare to similar therapies?
It is priced slightly higher than monotherapies like Januvia or Jardiance but offers the convenience of combination therapy, often justified by its clinical profile.
3. Are rebate and discount programs common for Glyxambi?
Yes. Manufacturers and pharmacy benefit managers (PBMs) offer rebates, discounts, and patient assistance programs to improve access and mitigate high out-of-pocket costs.
4. What impact might new combination therapies have on Glyxambi?
New therapies with improved efficacy, fewer side effects, or lower costs could reduce Glyxambi's market share, especially if launched before 2028.
5. How significant is Glyxambi's role in the global market?
While primarily marketed in the US, Glyxambi has limited presence in Europe and Asia, where regulatory approvals and pricing strategies differ.
References
- IQVIA. (2022). Pharmaceutical Market Analytics.
- FDA. (2017). Glyxambi Approval Letter.
- EvaluatePharma. (2022). World Preview of Diabetes Medications.
- U.S. CDC. (2022). National Diabetes Statistics Report.
- Drugs.com. (2023). Glyxambi Pricing and Reimbursement Data.
[1] FDA (2017). Glyxambi approval letter.
[2] IQVIA (2022). Pharma market insights.
[3] EvaluatePharma (2022). World diabetes drug sales.
[4] CDC (2022). Diabetes prevalence data.
[5] Drugs.com (2023). Glyxambi pricing.
