The era of unofficial, copycat weight-loss medications — which many assumed would quickly fade once brand-name supply issues were resolved — continues in full force, with no signs of slowing down. Although federal regulators initially sought to limit the use of such imitations, loopholes and inconsistent interpretations of the law have enabled them to persist alongside patented treatments, leaving patients, providers, and policymakers entangled in a complicated, high-stakes scenario.
The persistence of these copycat drugs stems largely from the shortage of high-demand brand-name treatments. When semaglutide, sold under well-known names such as Ozempic and Wegovy, and tirzepatide, marketed as Zepbound and Mounjaro, first entered the U.S. healthcare market, demand quickly outpaced supply. Confronted with long waits and dwindling availability, the Food and Drug Administration (FDA) temporarily loosened restrictions, allowing compounding pharmacies — specialized facilities permitted to customize or replicate medications under certain circumstances — to prepare their own versions of these injectable drugs. During this supply crisis, compounding offered a lifeline; pharmacists could legally produce similar formulations to meet patient needs.
However, with the shortages now officially resolved — semaglutide in early 2025 and tirzepatide in late 2024 — patients were expected to return to the pricier, officially sanctioned versions. This transition presented a major challenge: while effective, the original branded medications remain notoriously expensive, typically running into hundreds or even thousands of dollars per month, often without insurance coverage. Patients who had relied on cheaper compounded versions naturally balked at the dramatic price increase, viewing these high costs as a prohibitive barrier to continuation. Under the law, once branded versions were sufficient in supply, compounding pharmacies should have ceased manufacturing equivalents, since regulations explicitly bar them from producing what is essentially a direct copy of an FDA-approved medication.
Yet the reality on the ground is far murkier. Some businesses, such as telehealth outlets like Ro and Weight Watchers, appear to have discontinued sales of compounded GLP-1 drugs in compliance with strict legal interpretation. By contrast, other operations, including high-profile telehealth retailer Hims & Hers, argue that creative regulatory interpretations allow them to continue dispensing modified versions. Their defense frequently relies on subtle adjustments to claims of “personalization.” This may involve incorporating additional ingredients — vitamins B6 or B12, for instance, which are said to ease nausea — or slightly altering dosage strengths or delivery methods. Pharmacies then assert that these minor variations constitute a distinct formulation tailored to individual patients, a practice that, in principle, is consistent with the classical purpose of compounding: meeting unique patient needs that cannot otherwise be met by standard drugs.
Nevertheless, many experts contend that this justification stretches the definition of personalization to its limits. In practice, some pharmacies distribute identical so-called personalized formulations to thousands of patients, often via automated telehealth questionnaires where doctor-patient engagement is nominal at best. Such mass production and uniformity stand in tension with the spirit of compounding laws, which were designed to accommodate rare or individualized medical requirements — such as dye-free options for allergy sufferers or liquid preparations for people unable to swallow pills. For regulators and healthcare professionals, this trend raises unsettling questions: at what point does personalization become a thinly disguised mechanism for circumventing protections intended to preserve drug safety and integrity?
The FDA has not remained silent. The agency has issued multiple warnings about the inherent risks of compounded GLP-1 products, both during the shortage era and after supply returned to normal. Concerns range from dosing errors to mislabeled vials and questionable production consistency. In one recent enforcement action, the FDA sent a warning letter to Hims & Hers, criticizing its marketing claims, which implied that its compounded semaglutide was equivalent to FDA-approved versions when it was, in fact, not subject to the same rigorous review process. While these regulatory efforts signal heightened oversight, some observers argue that the FDA remains cautious, perhaps overly deferential to the sanctity of the patient-doctor relationship, a dynamic that can deter stronger interventions.
Parallel to government oversight, state authorities have begun charting their own course. For example, Ohio has taken steps to limit the scale of compounding by restricting batch sizes and cracking down on medspas dispensing the medications. At the same time, drugmakers such as Eli Lilly and Novo Nordisk — the companies responsible for the original patented formulations — have initiated lawsuits and other legal maneuvers in an effort to rein in the compounders. The situation has all the makings of a protracted regulatory tug-of-war, where pharmaceutical giants, scrappy compounders, cautious regulators, and opportunistic telehealth firms are all struggling to define their boundaries.
Beneath this legal and regulatory landscape lies a deeper issue: the towering price of the brand-name drugs. While manufacturers such as Eli Lilly and Novo Nordisk have begun lowering prices — dropping monthly costs from well over $1,000 to around $349–499 depending on the dosage — the financial burden remains significant. Meanwhile, compounded alternatives sell for a fraction of the cost, often around $199 per month, creating a powerful incentive for patients to continue seeking them out. This disparity, though narrowing, still defines patient decision-making, especially for individuals whose insurance plans refuse coverage for weight-loss related prescriptions. Industry experts acknowledge that while price should not theoretically influence compounding decisions, in practice it remains the undeniable factor driving demand.
Ironically, the very existence of compounded drugs may be accelerating downward price pressure on the originals: as these lower-cost substitutes proliferate, branded manufacturers are forced to compete by lowering their self-pay options. Patients, meanwhile, weigh the trade-off between lower prices and assurances of quality, safety, and regulatory approval. For some, the peace of mind of an FDA-approved product justifies the additional out-of-pocket expense. For others, economic constraints override these concerns, especially in a healthcare environment where even insured patients may struggle with unaffordable medication costs.
Adding further complexity are patent timelines and brand recognition. Semaglutide’s U.S. patent protections extend until 2031, whereas tirzepatide is protected until 2036. This has led many to speculate that certain companies may see little downside in prolonging compounded semaglutide sales, reasoning that any legal fight with Novo Nordisk might last long enough to become irrelevant by the time generics are permitted anyway. Compounding activity is also more prevalent with semaglutide, not only because its name is more familiar among the public but also because Eli Lilly strategically released lower-cost offerings for tirzepatide sooner, thereby dissuading widespread attempts to duplicate it.
What emerges is a case study in the dysfunction of the American healthcare marketplace. We have, on one hand, a proven class of drugs — GLP-1 agonists — that deliver health benefits so compelling they have been dubbed nothing short of a “miracle.” On the other hand, access is restricted by patents, pricing dynamics, and uneven insurance coverage. Patients understandably seek opportunities to bypass these barriers, while compounders, telehealth companies, and even opportunistic medspas identify lucrative openings to meet this unrelenting demand. Yet in exploiting gray areas of the law, they expose patients to potentially unsafe products and regulatory uncertainty. The broader tragedy is that a game-changing pharmaceutical innovation, capable of alleviating widespread health burdens associated with both obesity and diabetes, remains bound up in affordability crises and litigation entanglements.
Ultimately, the hope is that the future brings greater affordability of FDA-approved versions and, eventually, widespread access to generics once patents expire. Until then, the American healthcare system continues to operate in a state of uneasy compromise: extraordinary treatments exist, but access is uneven, trust is fragile, and patients remain caught in an expensive and often confusing bind, navigating a landscape where health, legality, and economics are perpetually at odds.
Sourse: https://www.businessinsider.com/compounded-ozempic-semaglutide-hims-hers-eli-lilly-novo-nordisk-fda-2025-9
