Eli Lilly is taking the fight against copycats to the telehealth front, suing four startups over its patented GLP-1 medications Mounjaro and Zepbound.
The pharmaceutical industry has long been a battleground for the production and sale of prescription medications, with companies like Eli Lilly fighting to protect their intellectual property. Recently, the giant pharmaceutical company escalated its efforts by suing four prominent telehealth startups that offer more affordable, off-brand versions of its patented best-selling GLP-1 medications ‘Mounjaro’ and ‘Zepbound’.
The Rise of Compounded GLP-1s
In recent years, compounded GLP-1s have become widely available through existing telehealth providers and startups that sprang up to cash in on the lucrative healthcare niche. These off-brand versions are not approved by the FDA but are often far more affordable than name-brand medications. According to industry estimates, at least 2 million people in the US were taking these medications as of November last year.
GLP-1s, or glucagon-like peptide-1 receptor agonists, are medications used to treat type 2 diabetes and obesity.
Compounded GLP-1s are customized versions of these medications created by pharmacies using individual ingredients.
This process allows for tailored dosages and formulations not available through traditional pharmaceutical channels.
Compounding GLP-1s can provide flexibility in treatment options for patients who require specific dosing or have allergies to certain ingredients.
Eli Lilly’s Lawsuits
Eli Lilly has filed lawsuits against four telehealth brands: Mochi Health, Fella & Delilah Health, Willow Health Services, and Henry Meds. The company alleges that each of these companies is selling knockoffs of its drugs, including untested added ingredients like vitamins and amino acids in an attempt to distinguish them from its name-brand medications.
Eli Lilly and Company is a global pharmaceutical giant founded in 1876 by Colonel Eli Lilly.
Headquartered in Indianapolis, Indiana, the company is known for developing innovative medicines that address some of the world's most pressing health issues.
With a rich history spanning over 140 years, Eli Lilly has made significant contributions to the medical field, including the development of insulin, which revolutionized the treatment of diabetes.
The company employs over 35,000 people worldwide and operates in more than 18 countries.
The Telehealth Companies’ Response
The telehealth companies have not responded to requests for comment on the lawsuits. However, Mochi Health has stated that it offers compounded GLP-1 medications that are ‘customized for medical necessity’ and that their use remains appropriate and legal when tailored to individual patient needs and prescribed by a licensed medical provider.
The Controversy Surrounding Compounded Medications
Compounding pharmacies are generally permitted to create customized medicines for patients even when they’re not in shortage. However, the crux of Eli Lilly‘s argument is that the medications telehealth companies are offering are not truly personalized because they are being mass-produced and prescribed to many patients.
The FDA’s Role
The FDA gave compounders a grace period to wind down their production of the drugs after the shortage was over. However, some companies have continued to offer tirzepatide products with add-on ingredients, unapproved dosages, or in different forms, such as oral versions.
The Future of Compounded GLP-1s
The future of compounded GLP-1s is uncertain, with some companies likely to continue selling these medications despite the lawsuits. A compounding trade group has filed a set of lawsuits against the FDA on behalf of clients, arguing that the agency prematurely declared the GLP-1 shortages over.
Conclusion
The war between Eli Lilly and telehealth startups over GLP-1 medications is a contentious issue with significant financial stakes. As new research continues to point to additional medical uses for these drugs, it’s possible that the situation could escalate further, leading to another shortage of these life-saving medications.
