Select Eli Lilly U.S. Patent Expiries

Select Eli Lilly U.S. Patent Expiries

September 20, 2024


Eli Lilly has experienced a remarkable growth surge driven by the success of its GLP-1 portfolio, which enjoys patent protection well into the 2030s. However, the company's overall portfolio presents a more nuanced picture of the opportunities and challenges that lie ahead.

Oncology Portfolio

In oncology, Lilly faces a patent expiration for Cyramza in 2026. On the other hand, Jaypirca and Retevmo enjoy compound patent protection until 2037, providing Eli Lilly with a substantial window of exclusivity. Interestingly, Retevmo already faces competition from a similar drug, Gavreto (Blueprint Medicines), which was launched around the same time. Both drugs are RET kinase inhibitors indicated for NSCLC and thyroid cancer. Despite the competition, Retevmo has outperformed its rival in sales, setting the stage for a continued battle between these two oncology therapies in the next decade.

Verzenio, Lilly's top-selling CDK4/6 inhibitor, generated $3.9 billion in global revenue in 2023, including a 52% increase in U.S. sales. With compound patent protection until 2031, Verzenio's performance against competitors Ibrance and Kisqali will be closely watched as we approach the latter half of the decade.

Ibrance, Pfizer’s CDK4/6 inhibitor, generated $4.7 billion in worldwide sales last year but loses basic patent protection in 2027. Kisqali, Novartis’s medicine in this class, faces its earliest compound patent expiration in 2028. Post-2028, Verzenio's performance against these competitors could reshape the CDK4/6 inhibitor market landscape.

Immunology Portfolio

Taltz is Eli Lilly's biggest-selling immunology drug, generating approximately $2.8 billion in revenue last year. With biologics data protection until 2028 and compound patent protection until 2030, Taltz represents a significant revenue stream for the company in the near future.

GLP-1 Portfolio

Beyond oncology and immunology, Lilly's strong GLP-1 portfolio contributes significantly to sustaining the company's patent lifecycle.

Trulicity

Trulicity, Eli Lilly's best-selling product overall, generated $7.1 billion in worldwide revenue last year. However, it will face patent expiration for both its U.S. compound patent and biologics data protection in 2027, potentially opening the door for generic competition and impacting its revenue stream.

Mounjaro and Zepbound

In the GLP-1 class, Mounjaro and Zepbound enjoy patent protection in the U.S. for four years after Novo Nordisk's Ozempic and Wegovy lose exclusivity. Although Novo Nordisk was first-to-market, Eli Lilly's GLP-1s have demonstrated superior weight loss efficacy, which contributes to a premium valuation.

It is worth noting that patent protection dates do not necessarily dictate when a drug will face competition from generic alternatives. Pharmaceutical manufacturers often negotiate agreements with potential generic competitors, among other strategic factors, which can influence the timing and extent of competition for a particular drug, even after its patent expiration.

Diversification and Risk Mitigation

To mitigate these risks and sustain long-term growth, Eli Lilly is actively pursuing diversification strategies, including the development of new products across various therapeutic areas like neuroscience, with the recent FDA approval of donanemab for treatment of early Alzheimer’s disease, and lebrikizumab for atopic dermatitis.

To navigate this landscape successfully, Eli Lilly must strike a balance between maximizing the revenue potential of its existing products and investing in the development of new, innovative therapies.


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