Novo Holdings’ Catalent Deal Nets Novo Nordisk Three Key Manufacturing Sites: What It Means for Patients and Compounded GLP-1s
Novo Holdings has cleared the last regulatory hurdle in its $16.5 billion acquisition Catalent manufacturing sites, which will net Novo Nordisk $11.5 billion in manufacturing sites. This move, designed to address surging and future demand for Semaglutide-based medications like Wegovy and Ozempic. With expanded manufacturing capacity, Novo is strengthening its position in the market and bolstering its argument against compounded medications. But despite these steps, the regulatory landscape for compounded semaglutide remains murky—and that has serious implications for patients.
Novo Nordisk’s Expanded Manufacturing Power
The deal gives Novo Nordisk control of three Catalent factories that will play a crucial role in producing semaglutide-based treatments, including its new treatment on the horizon, CagriSema. This acquisition is a massive strategic win for Novo Nordisk as demand for Semaglutide based drugs continues to significantly outpace supply. With the expanded capacity, Novo Nordisk has already reported that it’s semaglutide products are now “commercially available,” signaling an end to the shortages that have plagued the market.
However, the FDA has yet to officially remove semaglutide from its drug shortage list. This creates a gray area for compounded versions of the medication, which are currently allowed because of the shortage designation. Novo Nordisk’s increased production could tip the regulatory balance, leading the FDA to take semaglutide off the shortage list—and putting compounded options at risk.
Compounded Medications: A Shrinking Safety Net
Compounded semaglutide has provided critical access for patients during shortages and as an affordable alternative to branded medications. But this deal could hasten the decline of compounded GLP-1s for two reasons:
1. Novo Nordisk’s Argument Against Compounding
Novo has long argued that compounded medications are unnecessary and lack proper oversight. With its increased manufacturing power, Novo is doubling down on this stance, claiming it can now meet market demand for branded products like Wegovy and Ozempic.
2. The FDA’s Evolving Role
While tirzepatide has already been removed from the FDA’s shortage list (and is facing its own legal challenges), access to compounded tirzepatide hangs in the balance. If the FDA removes semaglutide from its list as well, compounded versions could face the same fate, cutting off an affordable option for patients.
What Does This Mean for Patients?
For patients, Novo Nordisk’s increased production capacity is both a blessing and a potential challenge:
• Improved Access to Branded Drugs
Expanded production should ease shortages of Wegovy and Ozempic, making these medications more readily available at pharmacies. For patients with robust insurance or the ability to pay out of pocket, this is a welcome development.
• Loss of Affordable Alternatives
For many patients, compounded versions of semaglutide (and tirzepatide) have been the only affordable option, often costing $150–$500 per month compared to up to $1,600 for branded drugs. If compounded medications are no longer available, patients without strong insurance coverage may struggle to access treatment.
• Affordability Remains a Major Barrier
While increased availability is a positive step, it doesn’t solve the affordability problem. For patients paying out of pocket, the high cost of branded medications remains a significant hurdle.
The Market Implications
This deal is part of a broader trend in the GLP-1 market. With Novo Nordisk gaining ground through this acquisition while Eli Lilly is ramping up production capacity of tirzepatide, the two pharmaceutical giants are tightening their control over the space. As these companies scale up production and expand their market share, compounded medications are increasingly being pushed to the margins.
Think of it this way:
Apple and Android
Walmart and Amazon
Visa and Mastercard
Coke and Pepsi….
Eli Lilly and Novo Nordisk
While Lilly and Novo are both scaling at a ferocious pace, they are simultaneously waging absolutely war on anything that may hinder their dominance.
Novo Nordisk’s move is also a signal to regulators. By expanding its manufacturing footprint and declaring its products commercially available, Novo is effectively challenging the FDA to act on compounded semaglutide. The removal of semaglutide from the master FDA shortage list would further consolidate Novo’s market power, leaving patients with no where to go, but the unregulated, and ever expanding grey market.
What Comes Next?
For patients, the future of compounded semaglutide hinges on two key developments: the FDA’s decision on semaglutide’s shortage status and Novo Nordisk’s ability to deliver on its promise of consistent supply. Until the FDA updates its master list, Semaglutide medications remain a critical option, but their days may be numbered.
Final Thoughts
Novo Holdings’ Catalent deal and Novo Nordisk’s subsequent acquisition of three manufacturing sites mark massive turning point in the GLP-1 market. While the increased production capacity could help resolve shortages, it also tightens big(ger) pharma’s grip on the market and threatens the affordability of these life-changing medications.
Sadly, 95% of people relying on compounds won’t see how big this news is… Suffice it to say, it’s tectonic. Everything will shift, and if you’re relying on compounds, this is a disturbing development.
Patients need to stay informed and continue advocating for access to affordable treatments. Whether it’s pushing for expanded insurance coverage, fighting for savings programs, or raising awareness in patient communities, the battle for equitable access is far from over.
At On The Pen, we’ll keep you updated on these developments and what they mean for your treatment options. If this article resonates with you, please share it with your networks, especially in Facebook groups and Reddit forums dedicated to GLP-1s. Together, we can ensure patient voices are heard in this evolving landscape.
Comments