Last Updated on March 6, 2026 by Chicago Policy Review Staff
In December 2024, Novo Nordisk discontinued insulin detemir (levemir) in the U.S. They cited manufacturing constraints, alternative insulins, and reduced formulary coverage. This decision removed one of only three basal insulin options. No generic could replace it since the FDA does not allow compounding of insulins, and expedited pathways still require extensive development. Thus, replacement options are not easily created. For millions of patients — children, pregnant women with gestational diabetes and those with Type 1 diabetes — the loss was not symbolic.
Corporations acted within their business interests. Policy failures made this predictable. Patients now pay the price. Detemir’s disappearance is not one company’s failure. It is a flaw in U.S. drug policy where innovation is rewarded, but access is not guaranteed once a drug becomes commercially inconvenient.
To manage blood glucose levels, individuals either use an insulin pump that delivers short-acting insulin continuously, or they rely on self-administered injections: a basal (long-acting) insulin for background control and short-acting insulin for glucose spikes (such as eating meals).
Pumps work. Copay caps help, but coverage is patchy. Costs can block access. Patients must receive training beforehand, and afterwards they can still be dislodged. Not everyone can or wants to use them.
Detemir’s core composition-of-matter patent expired in 2019. In theory, that should have opened the door to biosimilar competition and long-term access. In practice, its disappearance illustrates a central design gap in the U.S. drug system: While the framework rewards innovation through patent protection, it offers no mechanism to ensure continued access to essential medication once exclusivity ends.
Insulin glargine (lantus) can last more than 24 hours. Insulin degludec (tresiba) can last more than 42. Insulin detemir (levemir) is the only basal insulin with a comparatively shorter duration of action, typically providing coverage for approximately 14 hours in routine clinical use. Adverse effects like allergic reactions or poor tolerability make alternatives lifesaving.
Detemir’s flexibility mattered. Pediatric endocrinologists like Dr. Kannan Kasturi, MD, Medical Director of Pediatric Diabetes at Essentia Health, described how he used detemir to adjust overnight versus daytime insulin needs, especially in young children whose activity levels are unpredictable. Pumps, while useful, often proved difficult in his experience because children might pull them out or be noncompliant. Additionally, he described how adolescents playing sports relied on detemir because its shorter-acting profile helped prevent hypoglycemia during intense activity.
For pregnant patients, Dr. Florence Brown, Staff Physician and Co-Director of the Diabetes in Pregnancy Program at Joslin and Beth Israel Deaconess Medical Center, and Assistant Professor of Medicine at Harvard Medical School, emphasized that detemir’s shorter half-life allowed clinicians to respond quickly when insulin requirements shift, particularly during delivery, when insulin needs can drop sharply. The longer duration of glargine and degludec makes it harder to titrate, especially during pregnancy, which is where detemir shines. After delivery, insulin resistance can drop by up to 50% within the first 24 hours, requiring significantly less insulin in a short period of time. In interviews, several physicians noted cases of hypoglycemia, not by mismanagement, but by insulin that lingered too long.
Dr. Brown discussed a randomized control trial (RCT) conducted by Novo Nordisk comparing use of detemir to degludec in pregnant patients. While the study showed non-inferiority for degludec, Dr. Brown considered the study “limited in scope” because its main outcome was A1c. Dr. Brown explained that CGM time-in-range metrics would have provided a more meaningful assessment of glycemic control and its relationship to maternal and neonatal outcomes. Unlike A1c, which provides only a rough three-month blood glucose average, CGM offers minute-by-minute data, giving clinicians a much clearer picture of blood glucose patterns.
Although the trial endpoints were statistically valid, they did not capture detemir’s dosing flexibility physicians emphasized in interviews, particularly the capacity to adjust basal insulin more rapidly during periods of physiological variability.
Together, these perspectives highlight a key tension between study outcomes and clinical practice. While RCTs demonstrate statistical equivalence, the nuanced adjustments clinicians make with detemir, whether for children with variable activity patterns or pregnant patients requiring rapid insulin modulation, cannot be fully represented in trials that rely solely on A1c. Removing detemir from the market silently, as Novo Nordisk has done in the U.S., eliminates an option clinicians have relied on for decades to safely manage complex, real-world patient needs.
Removing detemir did not simply reduce “choice.” It eliminated an entire dosing profile from the market.
Insulin is regulated by the FDA as a biologic under the Public Health Service Act. Unlike small-molecule drugs, biologics are complex protein products manufactured in living cells, and much of their production process, such as, including cell lines, growth conditions, purification methods, and quality controls, is protected through trade secrets as well as patents. Developing a biosimilar insulin therefore requires substantial investment, extensive analytical and clinical testing, and regulatory review that is more complex than the approval process for traditional generics. As a result, even when patents expire, competition does not automatically follow: biologics require tacit knowledge, long development timelines, and massive financial investment.
Novo Nordisk now makes over half the world’s insulin and far more money from GLP-1 drugs like Ozempic and Wegovy. Millions of Americans rely on insulin daily, though smaller groups — children, pregnant patients and Type 1 diabetics — face the greatest need for tailored dosing. Detemir was low-margin and competed with Novo’s own patent-protected degludec. Once it was withdrawn, the economics collapsed: no guaranteed demand, no access to manufacturing know-how, no regulatory flexibility. Public efforts did little. U.S. investment has focused on glargine, leaving clinically distinct options vulnerable. Alison Smart, founder of the Alliance to Protect Insulin Choice, said this allowed detemir to quietly vanish even as glargine biosimilars proliferated.
The FDA must take a more active role in preserving access to essential biologics. Manufacturers should be required, upon approval or patent expiration, to deposit core manufacturing know-how into a secure, regulated escrow. If a product is discontinued, that information could then be licensed to a qualified manufacturer under FDA supervision. This would ensure that lifesaving medicines remain available even if the original manufacturer exits the market.
Second, the FDA must create a fast-track pathway for off-patent biologics. If safety has already been proven, follow-on manufacturers could bring the drug to market without repeating years of costly testing. This would prevent gaps in access to essential medicines.
Third, public funding for domestic drug manufacturing must prioritize therapeutic diversity, not just low cost. Manufacturers receiving taxpayer support must maintain multiple clinically distinct insulin options. Losing any of these options undermines resilience and patient safety.
Detemir’s disappearance was preventable. It was the predictable result of a system that treats access as a market outcome rather than a policy responsibility. Novo Nordisk had already demonstrated that degludec was safe before exiting, but non-inferiority addresses safety, not clinical interchangeability. Detemir’s unique dosing profile cannot be fully replaced. The FDA could still create a viable path forward, but without reform, detemir will not be the last essential biologic to quietly vanish.
Insulin was discovered a century ago with the explicit belief that it belonged to humanity. It was not patented intentionally. Allowing a proven, lifesaving insulin to disappear, not because it failed patients, but because it no longer maximized profit, should force a reckoning.
If post-patent drugs can die this easily, the problem is not Novo Nordisk alone, even if they certainly are a key player. It is the system that lets them.
Novo Nordisk and the FDA both retain the power to prevent detemir’s disappearance. Choosing not to act is not a neutral decision — it is a policy choice with consequences for patients.