Welcome to “A to Z: Drugs in Highlight: O is for OZEMPIC®
This series is designed to delve into the intricate realm of pharmaceutical drugs. As the world of pharmaceuticals continues to evolve with new discoveries and emerging challenges, we aim to shed light on the diverse array of medications available today, ranging from blockbuster medications to those that may not be as familiar. Whether you’re a healthcare professional, a student, or simply someone with a curious mind, “A to Z: Drugs in Highlight” promises to be an enlightening and engaging series.
O is for OZEMPIC®
OZEMPIC (from Novo Nordisk) is used to treat type 2 diabetes in adults.
How it works:
The active substance in OZEMPIC® is semaglutide. Semaglutide is a modified version of the human hormone glucagon-like peptide-1 (GLP-1). It has 31 amino acids and includes modifications that make it more stable and longer-lasting than GLP-1. Semaglutide is a “GLP-1 receptor agonist”. It acts in the same way as GLP-1 by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels. It also prevents your liver from releasing stored sugars and reduces food intake by lowering appetite and slowing digestion.
Semaglutide
OZEMPIC® is administered once a week via a self-injection pen under the skin of the stomach, thigh, or upper arm.
Market impact:
OZEMPIC® is approved for marketing in numerous countries, including the United States (approved by the FDA in May 2017) and Europe (approved by the EMA in February 2018).
Millions of diabetic patients worldwide have been treated with OZEMPIC®. In 2023, sales of OZEMPIC® soared by 60% to USD 13.9 billion. This surge in popularity has been attributed to its dual benefits for type 2 diabetes and weight loss, high efficacy, and convenient once-weekly dosage. The demand for OZEMPIC® continued to rise significantly in 2024, partly due to its off-label use for weight loss, with shortages reported in the United States, Europe and Australia.
Patent protection:
Numerous ‘primary’ patents protect the chemical entity semaglutide worldwide (see, for example, EP1863839B1 and EP2322546B1). Novo Nordisk has also filed many ‘secondary’ patents covering various aspects of the semaglutide technology, including formulations, preparation methods, and dosage regimens. For example, US10335462B2 relates to a method of treating type 2 diabetes, comprising administering semaglutide once weekly in an amount of 1.0 mg to a subject in need thereof.
Novo Nordisk has fiercely defended its patent rights, engaging in litigation with generic manufacturers such as Dr Reddy’s. Apotex and Sun pharmaceuticals. More recently, in January 2025, Novo Nordisk and Mylan Pharmaceuticals settled a patent dispute and validity challenge related to US10335462B2. Novo Nordisk scientists have even published a peer-reviewed study revealing the differences between their branded products and various imitations. The study tested 16 injectable formulations of semaglutide sourced from compounding pharmacies, telehealth providers, and medical spas. It concluded that these copied products were inferior and may pose safety risks, emphasizing the need for regulatory intervention.
The ‘primary’ patents are set to expire in 2026, while the ‘secondary’ patents extend protection until 2033. Consequently, generic versions might start appearing in 2026, but full generic competition may not occur until at least 2033.
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