Are there generic options available for Humulin R (Regular Insulin) U-500, a concentrated insulin formulation of 500 units/mL, for patients with high insulin requirements?

Generic Availability of Humulin R U-500 Insulin

There are currently no FDA-approved generic versions of Humulin R U-500 (concentrated regular insulin 500 units/mL) available in the United States. 1

Current Market Status

• Humulin R U-500 remains a brand-name product manufactured by Eli Lilly, available in both vial and prefilled pen formulations, with median costs of approximately $142-178 for vials and $184-230 for prefilled pens per the 2024 American Diabetes Association pricing data. 1

• Unlike some other insulin products where biosimilar or follow-on products have emerged (such as insulin glargine U-100 biosimilars at approximately $95-190), no such alternatives exist for U-500 concentrated insulin. 1

Why U-500 Has No Generic Alternatives

• U-500 regular insulin is a highly specialized concentrated formulation indicated specifically for patients requiring more than 200 units of insulin daily, representing a relatively small market segment compared to standard U-100 insulins. 1, 2

• The complexity of this five-times concentrated formulation, combined with its unique pharmacokinetic profile (functioning as both basal and prandial insulin with delayed onset and longer duration than U-100 regular), creates significant regulatory and manufacturing barriers to generic development. 1

Cost-Effective Alternatives to Consider

If cost is a primary concern and the patient does not absolutely require U-500 concentration:

• Human regular U-100 insulin vials are available for approximately $25-172 per vial (including Walmart's $25 option), representing substantial cost savings. 1

• Human NPH U-100 insulin vials similarly cost approximately $25-172 per vial. 1

• Converting to a basal-bolus regimen using U-100 vials (NPH or glargine for basal coverage plus regular or rapid-acting analog for prandial coverage) can achieve similar glycemic control using standard U-100 syringes, which reduces concentration-related dosing errors and provides significant cost savings if U-500 is not medically necessary. 2

Critical Safety Consideration

• If U-500 insulin must be used, the vial formulation requires mandatory prescription of dedicated U-500 syringes to prevent fatal 5-fold dosing errors that can occur if standard U-100 syringes are mistakenly used. 1, 2

• Prefilled pens are strongly preferred over vials to minimize dosing confusion and administration errors. 1, 2