The US Food and Drug Administration (FDA) announced on Wednesday, October 2, that the two-year shortage of Eli Lilly's popular weight-loss and diabetes medications, Mounjaro and Zepbound, has come to an end.
This news brings relief to many patients who have struggled to find these medications. According to the FDA, Eli Lilly now has enough supply of these drugs to meet both current and future demands across the nation.
Supply Issues for Mounjaro and Zepbound Resolved
Since 2022, both Mounjaro and Zepbound, which work by stimulating the hormone GLP-1 and suppressing appetite, have faced shortages. This was largely due to a dramatic increase in demand for weight-loss drugs, as many people sought help in managing their weight.
The FDA had previously placed these medications on a shortage list, which allowed compounding pharmacies to create their own versions to help fill the gap. Compounding pharmacies are known for customizing medications to meet specific patient needs.
However, with the FDA's announcement to end the shortage designation, this move is seen as a setback for these pharmacies, which have grown significantly in the past two years, said Reuters.
Eli Lilly has claimed that its tirzepatide-based drugs are now "commercially available," and the FDA has supported this statement. However, the agency has warned that while the overall supply has increased, patients and doctors might still experience some local supply issues as the medications are distributed to pharmacies.
To keep up with the rising demand for these weight-loss and diabetes medications, Eli Lilly has made significant investments to improve its manufacturing capabilities.
According to Patrik Jonsson, executive vice president at Eli Lilly, the company is committed to ensuring a steady supply of safe medications for patients. However, the FDA cautioned that patients may still face challenges in finding specific dosages of Mounjaro and Zepbound.
The competition in the weight-loss drug market has intensified between Eli Lilly and its rival, Novo Nordisk, which produces Ozempic and Wegovy. Both companies are investing billions to enhance their production processes and meet the increasing demand for their products, according to The Washington Post.
Recently, Eli Lilly's attorneys sent letters to healthcare providers asking them to stop prescribing non-branded versions of their medications, claiming these alternatives do not meet the safety standards of their approved drugs.
There is currently no generic version of tirzepatide, the active ingredient in Mounjaro and Zepbound, or semaglutide, the active ingredient in Ozempic and Wegovy, that is approved by the FDA. This means that the alternatives provided by compounding pharmacies do not have the same level of regulation and approval.
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Eli Lilly Grows Its Market
While these pharmacies have claimed that their versions are not just copies of Eli Lilly's products, the FDA has advised caution regarding these unapproved medications.
The implications of the FDA's decision to end the shortage are still unfolding. Many patients report having difficulty finding Mounjaro and Zepbound, even though Eli Lilly asserts there is enough supply.
Pharmacies that produce their own versions of these medications can offer them at a lower price compared to Eli Lilly and Novo Nordisk, making them more accessible for some patients.
However, following the FDA's announcement, these pharmacies are now required to stop producing their compounded versions of Mounjaro and Zepbound.
Scott Brunner, the CEO of the trade group Alliance for Pharmacy Compounding, expressed concern for patients who relied on these compounded medications. He noted that patients may suddenly find their prescriptions cannot be filled, leaving them without their needed medications.
While pharmacies may still be able to create their own versions of Ozempic and Wegovy, the FDA has classified semaglutide as still being in shortage.
To increase its market presence, Eli Lilly began selling vials of the lowest starter dose of Zepbound through its direct-to-consumer website. As demand for Mounjaro and Zepbound continues to rise, Lilly has invested billions into expanding its production capabilities. This includes building new manufacturing sites and forming partnerships with contract drug manufacturers.
With these weight-loss medications, patients have been able to lose significant amounts of weight. Clinical trials show that some individuals lost up to 20% of their body weight while using these medications. Analysts project that the revenue generated from these therapies could reach an astounding $150 billion by the early 2030s.
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