By Jeff Cohen
The world of healthcare marketing is evolving, particularly in the realm of GLP1s. With skyrocketing demand for treatments like semaglutide-based Ozempic and Wegovy, and Eli Lilly’s tirzepatide-based Zepbound and Mounjaro, the industry faces unprecedented challenges and opportunities, while compounders and healthcare platforms utilizing compounded medications are facing increasing hardships to be serve the same patient population that Pharma seeks to serve.
The recent global surge in GLP-1 receptor agonists (e.g., Ozempic and Wegovy), has been fueled by their efficacy in controlling diabetes and aiding weight management. Novo Nordisk and Eli Lilly, the two biggest players in the GLP space, providing the only FDA approved version of the medication, have recently taken strides to protect their market share, particularly concerning compounded suppliers and platforms utilizing compounded GLPs.
Novo Nordisk’s Trademark Battles
Novo Nordisk has been aggressively protecting its intellectual property and trademarks, filing lawsuits against numerous companies marketing compounded semaglutide products falsely advertised as being equivalent to FDA-approved drugs. Companies like Ekzotica Corp.’s Cosmetic Laser Professionals Med Spa and Effinger Health’s Nuvida Rx Weight Loss in Florida recently reached confidential settlements with Novo. These settlements have permanently prohibited these businesses from using Novo Nordisk trademarks, logos, or “misleading” claims about their products being FDA-approved.
The lawsuits, filed under the Lanham Act, indicate that Novo Nordisk is focused on preventing consumer misinformation and ensuring that only FDA-approved versions are associated with its brand name. The Lanham Act protects trademarks from unauthorized use, supporting Novo’s claims against compounded versions that may not provide the same quality or safety assurances as branded treatments like Ozempic.
Eli Lilly Joins the Legal Front
Similarly, Eli Lilly has initiated lawsuits against medical spas and online vendors marketing products containing tirzepatide, the active ingredient in Zepbound and Mounjaro. These lawsuits also target unauthorized competition, aiming to uphold product integrity and protect consumer safety.
Novo Nordisk vs. Apotex and Generic Competition
Beyond trademark disputes, Novo Nordisk recently filed a lawsuit against Canadian pharma company Apotex to block the production of generic versions of Rybelsus, its oral semaglutide medication. The lawsuit, citing 10 patent infringements, underscores the company’s commitment to retaining market exclusivity until patents expire between 2030 and 2034.
The FDA plays a pivotal role in regulating these life-altering drugs, ensuring that products meet rigorous safety and efficacy standards. Compounded versions of semaglutide and tirzepatide, however, sometimes bypass these regulatory processes (e.g., when not provided via a compound pharmacy). The potential risks to consumers are highlighted by Novo and Eli.
The FDA noted that it received 346 reports of adverse events associated with compounded semaglutide and 136 reports tied to compounded tirzepatide. Investigations revealed that some copycat products contained high levels of impurities—up to 33%—or lacked active ingredients entirely, endangering patient health.
Regulatory bodies are urging stricter compliance measures to prevent such products from entering the public domain, emphasizing the importance of only using approved medications.
Marketing Implications for Sellers of Weight Loss Medications
For healthcare providers and marketers in the weight loss medication sector, these legal and regulatory developments have several key implications, especially in the pursuit of legally compliant marketing practices and maintaining trust with consumers.
- Transparent Communication and Branding
Marketers must clearly distinguish FDA-approved products from compounded or non-regulated alternatives. Compounded GLPs are, by definition, not FDA approved. Pharma actions reveal and extremely broad view of what they consider to be misleading. Compounders and platforms using compounded medications need to take heed of this inclination, especially when it comes to marketing and advertisement.
- Pertinent Disclosures
Disclosing the fact that GLPs might be compounded and hence not FDA approved medications is something all compounded GLP platforms need to consider disclosing, if only to avoid the “misleading” challenge.
- Clinical Leadership
Wellness based platforms, including those which are centered on GLPs, must ensure they follow a clinical leadership model instead of a product sales model. While it can be easy to skip steps in a heavy patient demand driven business, it’s essential for clinicians to properly examine, diagnose, prescribe, treat and document.
- Investing in Compliance
Healthcare businesses of all types need to be aware of the “environmental risks” associated with their industry. For GLP centered businesses, knowing what Pharma is doing and how they think is essential to staying in business.
Opportunities for Innovation
While the lawsuits and safety concerns highlight ongoing challenges in the sector, they also present opportunities for innovation in healthcare platform design, especially as it relates to clinical leadership, and with respect to healthcare marketing strategies.
The Bigger Picture
The healthcare marketing landscape for weight loss medications is at a crossroads. With growing consumer demand, evolving legal and regulatory frameworks, and increasing pressure for transparency and safety, the sector offers both challenges and opportunities for clinical platforms and marketers alike.
By adopting smart policies and procedures and in service training staff about them, by scrubbing websites and marketing materials and helping staff understand what to say and what not to say, these businesses will help more patients and be more stable. Investing in legal compliance and fostering consumer and employee education will go a long way to being able to stay in business.
