Novo Nordisk, Maker of Ozempic, Became Europe’s Most Profitable Company in 2023
Happy New Year.
Did you overindulge in food during the holidays?
Turning to the weight loss drug Ozempic may be on your mind.
If so, you are not alone.
In a year when most pharma company stocks were in the doldrums, Ozempic became the breakout star in the constellation of weight loss products during 2023, driving Novo Nordisk’s stock price up by more than 50% to a market cap of over $420 billion, allowing it to briefly surpass the luxury goods maker LVHM as Europe’s most valuable enterprise and singlehandedly keeping its home country Denmark out of recession.
Ozempic and its sister product Wegovy have become pop culture famous, the topic of TikTok videos and celebrity tabloid guessing games about which Hollywood star is or is not relying on Ozempic/Wegovy to maintain their waistline.
High Prices and Shortages led the FDA to Warn about the Rise of Counterfeit Ozempic Products on the Black Market
Where large profits loom, bad actors are sure to follow.
A combination of Ozempic/Wegovy shortages and high prices (upwards of $1000+ per prescription in many cases, if paying retail prices) has fed a growing gray and black-market offering “generic Ozempic” and the like.
After fielding reports of adverse reactions from consumers, the FDA had to issue a warning to consumers in December 2023 to be on the lookout for counterfeit products claiming to be Ozempic or a related weight loss drug.
While it’s hard to get actual statistics on black market sales, some consumers appear to be attempting to import Ozempic and other Liraglutide/Semaglutide-based products from overseas markets, where prices may be cheaper. (However, the quality may be compromised – as these products need to be chilled but not frozen otherwise they lose their effectiveness).
Another possible source of gray market products is compounders, a nominally legitimate type of pharmacy operation licensed to remix/reformulate drugs (called “compounding” in the industry), though it’s unclear how this approach alone can lead to lower prices for consumers if done legitimately.
What’s more likely is that illegitimate operations are producing fully counterfeit drugs to sell to the black market, marketing them as “generic Ozempic” and the like, potentially putting consumers at risk.
Novo Nordisk’s Liraglutide Patents are Expiring, Paving the Way for Generic Versions of Victoza in 2024
As we wrote in our previous article, there are multiple generations and versions of Novo Nordisk’s weight loss medication.
The active ingredient in the first-generation products, known as Liraglutide, required a daily injection. Liraglutide is marketed for Type II diabetes control under the Victoza brand, while the version targeted at weight loss is sold as Saxenda.
Unfortunately for Novo Nordisk, Liraglutide patents have started to expire around the world, and the company has agreed drop pending litigation and to not intervene against generic drug makers, such as Sandoz, who plan to distribute copycat versions of Victoza in 2024.
What about the patents for Ozempic and Wegovy that use Semaglutide as their active ingredient?
The generic drug manufacturer Mylan Pharmaceuticals (a subsidiary of Viatri) brought a suit against Novo Nordisk in the US, claiming the patent for Semaglutide (used in Ozempic/Wegovy) should be invalidated as it was (per the plaintiff’s assertion) simply a reformulation of Liraglutide’s delivery mechanism to allow for weekly injections rather than daily ones.
In October 2023, the US Patent Office’s appeals board swatted down Mylan’s patent challenge to Semaglutide, so Novo Nordisk’s IP for Ozempic/Wegovy is safe for now, meaning there won’t be a legitimate generic version of these drugs available any time soon – with the possible exception of the Brazilian market, whose patent court refused to extend the patents for Semaglutide used in Ozempic/Wegovy.
Eli Lilly Joins the Ozempic Party with its New Class of Dual-Agonist Weight Loss Drugs
Seeing the success Novo Nordisk has had with Ozempic, the pharma giant Eli Lilly is eager to break into the weight loss drug market in a major way with its new class of dual-agonist drugs.
Unlike Novo Nordisk’s single-agonist drug compounds Liraglutide and Semaglutide which only work to affect one “hunger hormone,” e.g. the glucagon-like peptide-1 (GLP-1), Lilly’s new weight loss drugs are a new class of “dual-agonist” weight loss drugs, which act on two hormones: the glucagon-like peptide-1 (GLP-1) and the glucose-dependent insulinotropic polypeptide (GIP).
This dual combination may give Lilly an advantage in the marketplace. Clinical trials showed that adults taking these dual agonist class drugs from Lilly lost 21% of their body weight (when taking the highest dose) compared to 15% weight loss among adults taking Novo Nordisk’s Wegovy.
Lilly’s first entry in the market using this new dual-agonist mechanism was Trulicity, a daily injectable medication (with the active ingredient Dulaglutide) for use by type 2 diabetic patients.
Lilly is now rolling out a major marketing push to promote their “second generation” dual agonist weight loss drugs which use Tirzepatide as the active ingredient – the two approved versions of these drugs are Zepbound (which was approved by the FDA in August 2023 for weight loss) and Mounjaro (prescribed for type 2 diabetics).
Like their Ozempic/Wegovy competition, these second-generation drugs are time-released so that patients only have to administer injections once a week rather than daily.
Are There Long-Term Side Effects from Taking Ozempic and Other New Weight Loss Medications?
Given the popularity of these new classes of weight loss drugs, they may be here to stay, and not just in North America and Europe, but around the world.
For example, some doctors have recently petitioned the World Health Organization (WHO) to put Liraglutide class medications (Victoza/Saxenda) on WHO’s “Essential Medicines List,” which would encourage national health agencies and insurance companies to prescribe and pay for it.
But are we sure of the long-term consequences of using these weight-loss drugs?
First, some good news.
A study of 17,500 overweight or obese people released in August 2023 indicates that using the Wegovy weight loss drug is associated with a 20% lower incidence of heart attack, stroke, or death from heart disease compared to those on a placebo. The underlying reason for this result is not clear from the study; presumably, losing eight by itself helps improve heart health-related outcomes.
But not all news is good news.
There have been some drug safety concerns about possible side effects caused by Liraglutide and Semaglutide, which is not unexpected given the massive uptake in the use of these weight loss products.
One concern early on was a possible connection between Novo Norkdisk’s Victoza (Liraglutide) and pancreatic cancer; however, in 2022, the company prevailed in a liability lawsuit.
More recently, the EU has brought up a potential “causal association” between long-term use of Glucagon-like peptide-1 (GLP-1) receptor agonists and thyroid cancer. More study is recommended.
In the US, there are media reports from CNN that some long-term weight loss drug patients say they are experiencing cases of gastroparesis, a condition in which the stomach’s muscles become weakened or partially paralyzed, which can slow or stop the digestive system, leaving partially digested food in the stomach.
Another risk for patients using these new weight loss drugs is accidental overdose; in these cases, patients misunderstand their prescription dose and take the wrong amount. (Taking 10x the correct amount is reportedly a common error for first-time users.) Or patients forget they took the drug earlier and mistakenly take a substantial additional dose.
In light of this, calls to poison control centers concerning weight loss drugs have jumped 1,500%. In some cases, overdosed patients require hospital care to address issues such as hypoglycemia, nausea/vomiting, or dehydration.
The final concern is how to wean yourself off these drugs if you choose to.
Patients typically report that their original appetite returns as soon as a week after discontinuing the drug, leading to higher blood sugar levels and, for many patients, significant weight gain.
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