Novo Nordisk’s Ozempic, also known as semaglutide, is a drug generally used to treat type-2 diabetes. However, the market for Ozempic is facing major shortages in supply globally due to its off-label use. The drug has gone viral over social media due to its side effect- weight loss. Amidst all this, the legal state of Ozempic has been looking glum with it facing patent disputes and also, a rising issue involving its counterfeits.
Ozempic’s Patent Dispute:
Since early October, Viatris, a healthcare corporation specializing in the manufacture of generic drugs has challenged two of Novo Nordisk’s patents in the US Courts. While the United States Patent and Trademark Office (USPTO) Tribunal initially rejected Viatris’ attempt at challenging the patents, it later signed off on Viatris challenging another one of Novo Nordisk’s patents.
Of all of Novo Nordisk’s patents which are under scrutiny, the one under the most scrutiny is the patent numbered 10,335,462. It talks about the dosage of the drug. While the patent was issued in 2019 and covers the drug till 2033, the USPTO Tribunal its decision stated that Viatris was most likely to prove this patent invalid.
While oral arguments for the patents covering the drug are set to begin in July next year, Novo Nordisk has a lot at stake when it comes to Ozempic. The drug accounted for $3.2 billion in sales in the second quarter of the previous financial year for Novo Nordisk and the company was swift to file a case of patent infringement against Viatris when it was made aware of a patent application made by the latter for a drug that was similar in composition and dosage to its blockbuster drug Ozempic.
Counterfeit Ozempic Pens:
A spike in demand for Ozempic in the market has caused a shortage in its supply. This gave rise to a favourable environment wherein the market for counterfeits of the said drug thrived. The surge in demand for the said drug is rooted in its potential weight loss properties making it famous amongst consumers. While initially only taken by celebrities for weight loss, it went viral over the social media platform TikTok sometime last year. Following this, the drug has seen a huge rise in its consumer base which has eventually led to the supply shortage it is facing now.
The counterfeit market for Ozempic is growing globally with no traceable source as to where these counterfeits are being produced.
Both the patent dispute and the menace of counterfeits can have detrimental impacts on the sale of Ozempic. The untraceable nature of the manufacture and smuggling of the counterfeit Ozempic drug has made it arduous for law enforcement bodies to pinpoint the brain behind this crisis. With the patent for the drug already under threat from Viatris’ challenge in the USPTO Tribunal, the threat which is looming over the block buster drug is only growing day by day.