Public record
Insulin degludec: the public record
Each table is computed from the named federal dataset as of its data date; the method is under each one.
Label
FDA label facts for insulin degludec
The FDA label read for insulin degludec (Tresiba, application BLA203314) was last revised on 2022-07-01. It carries no boxed warning. Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2022-07-01 | |
| Label read | Tresiba | BLA203314, brand-name application |
| Boxed warning | No | |
| Indications section opens | quoted in note | "TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus." |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
How this was calculated
Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.
One label: the newest prescription label for single-ingredient insulin degludec from an original manufacturer
Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.
Medicare Part D
Medicare Part D spending on insulin degludec
Medicare Part D spending on insulin degludec products was $1.85B in 2024 across 2,321,262 claims, compared with $1.81B in 2023 (+2.3%). Average spending per claim was $798, before rebates.
| Measure | Value | Note |
|---|---|---|
| Total spending, 2024 | $1.85B | |
| Total spending, 2023 | $1.81B | |
| Change in spending, 2023 to 2024 | +2.3% | |
| Claims (prescription fills), 2024 | 2,321,262 | |
| Average spending per claim, 2024 | $798 | |
| Tresiba Flextouch U-200: spending, 2024 | $973.9M | 893,822 claims |
| Tresiba Flextouch U-100: spending, 2024 | $825.8M | 1,281,963 claims |
| Tresiba: spending, 2024 | $33.5M | 51,551 claims |
How this was calculated
Summed total spending and claims over every brand and generic row with this generic name in the CMS file, using the Overall manufacturer rows. Combination products excluded. Average per claim is spending divided by claims.
Every single-ingredient insulin degludec product in Part D (Tresiba Flextouch U-200, Tresiba Flextouch U-100, Tresiba), 2024.
Gross drug cost before manufacturer rebates, so net cost is lower. Part D excludes some uses by law (for example erectile dysfunction, weight loss and hair growth), so claims reflect covered uses only. Compounded products are not included.
Medicaid
Medicaid prescriptions for insulin degludec by state
State Medicaid programmes paid for 249,204 insulin degludec prescriptions in 2025, with $143.8M reimbursed before rebates. California reported the most (42,586), followed by Texas (17,629) and New York (14,711); 51 states and territories reported any.
| Measure | Value | Note |
|---|---|---|
| Prescriptions paid by Medicaid, 2025 | 249,204 | |
| Total reimbursed before rebates, 2025 | $143.8M | |
| States and territories reporting | 51 | with at least one count CMS did not suppress |
| California | 42,586 prescriptions | $28.1M reimbursed |
| Texas | 17,629 prescriptions | $8.4M reimbursed |
| New York | 14,711 prescriptions | $8.6M reimbursed |
| Connecticut | 14,495 prescriptions | $10.0M reimbursed |
| Indiana | 13,652 prescriptions | $9.2M reimbursed |
How this was calculated
Matched each Medicaid product code to the FDA NDC Directory by labeler and product code, kept finished single-ingredient products, then summed prescriptions and reimbursement by state. National roll-up and suppressed rows dropped.
All single-ingredient insulin degludec products in the FDA NDC Directory, fee-for-service and managed care, 2025
Counts under 11 are suppressed by CMS and left out, so totals are a floor. Amounts are before rebates. Differences between states reflect programme size and coverage rules. Compounded products are not included.
Pharmacy cost
Pharmacy acquisition cost (NADAC) for insulin degludec
Retail pharmacies paid an average of $11.34 per mL for INSULIN DEGLUDEC 100 UNIT/ML VIAL as of 2026-11-11, compared with $11.37 twelve months earlier (-0.3%). This is a pharmacy purchase cost, not a patient price.
| Measure | Value | Note |
|---|---|---|
| INSULIN DEGLUDEC 100 UNIT/ML VIAL | $11.34 per mL | 12 months earlier $11.37 (-0.3%) |
| INSULIN DEGLUDEC FLEXTOUCH 100 UNIT/ML PEN | $11.39 per mL | 12 months earlier $11.38 (+0.1%) |
| INSULIN DEGLUDEC FLEXTOUCH 200 UNIT/ML PEN | $22.74 per mL | 12 months earlier $22.73 (+0.0%) |
How this was calculated
Matched NADAC product codes to the FDA NDC Directory, kept finished single-ingredient products, and listed the product descriptions with the most package codes. The earlier price is the same package code in the file one year before.
Generic versions of insulin degludec in the weekly NADAC file of 2026-11-11, compared with the file of 2025-11-12
NADAC is the average invoice price retail pharmacies pay, from a voluntary survey. It leaves out rebates, dispensing fees and markups, and it is not what a patient or insurer pays. Compounded products are not surveyed.
Clinical studies
Registered clinical studies of insulin degludec
ClinicalTrials.gov lists 251 registered studies that name insulin degludec as an intervention as of 2026-11-11. Of these, 8 are recruiting, 207 are completed and 87 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 251 |
| Recruiting now | 8 |
| Not yet recruiting | 4 |
| Completed | 207 |
| Terminated, withdrawn or suspended | 7 |
| Phase 3 (including phase 2/3) | 87 |
| Phase 2 (including phase 1/2) | 19 |
| Phase 1 | 65 |
How this was calculated
Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.
Studies whose intervention field matches insulin degludec, any condition, any country, all statuses
A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.
Articles on Insulin degludec
- Tresiba Cost vs. Alternatives: Basal Insulin Compared
- How to Safely Stop Tresiba (Insulin Degludec): A Clinical Discontinuation Protocol
- Tresiba Duration of Action: 42+ Hours Explained
- Tresiba Manufacturer Copay Program: How to Get Insulin Degludec for $35 or Less
- Tresiba Hair and Skin Changes: What the Clinical Evidence Actually Shows
- Tresiba Manufacturing, Supply & Shortage History