Novo Nordisk files 14 more lawsuits over compounded semaglutide

Novo Nordisk said on Aug. 5 that it filed 14 new lawsuits against companies that sell compounded drugs labeled as "semaglutide," extending a legal campaign the company says now totals 132 complaints in federal courts across 40 states ^[1].

The new filings target two groups the company had not emphasized in earlier rounds: pharmacies that compound "semaglutide" under what Novo calls a "fake guise of personalization," and telehealth companies that the company says let corporations rather than doctors steer patients toward compounded products, in violation of California law ^[1]. Novo Nordisk did not name the defendants or say in which courts the new cases were filed ^[1].

Courts have issued 44 permanent injunctions in similar cases, according to the company, barring defendants from conduct that includes compounding "semaglutide" and claiming compounded products are FDA-approved, safe, or equivalent to Wegovy or Ozempic ^[1]. Some defendants have also been ordered to forfeit profits the company describes as illegally obtained ^[1].

Novo points to federal warnings about compounded GLP-1 drugs. The FDA's latest alert, dated July 29, tells patients and healthcare professionals about the risks of unapproved GLP-1 drugs and includes reports of patients overdosing by giving themselves five to 20 times the intended dose and needing hospital care ^[1].

The company also cites a Brookings Institution report stating that many compounded "semaglutide" products rely on synthetic active pharmaceutical ingredient imported from facilities in China that lack FDA oversight or quality controls. According to Novo's account of that report, 60% of Chinese manufacturers importing "semaglutide" for use in compounding or further manufacturing are not permitted to distribute that ingredient in China for human drugs ^[1]. FDA data cited in the announcement shows that all "semaglutide" imported into the US designated for compounding since June 2023 came from suppliers in China ^[1].

"Patients deserve safe, effective treatments from companies they can trust. No one should have to gamble with their health by using knockoff drugs made with ingredients that lack oversight and safety standards," said Dave Moore, executive vice president of US operations for Novo Nordisk ^[1].

Novo Nordisk has run consumer education campaigns called "Check Before You Inject" and "Choose The Real Thing," and operates a website, semaglutide.com, about compounded and counterfeit products. The company says all doses of Wegovy and Ozempic are available nationwide ^[1].

Why it matters for patients

A compounded product containing "semaglutide" is not an FDA-approved drug. Wegovy and Ozempic are the FDA-approved brand-name versions of semaglutide ^[1]. Marketing language about "personalization" does not mean a compounded product went through FDA review for safety and effectiveness, and the lawsuits allege that some sellers blur that distinction ^[1].

The cases name businesses, not the patients who bought from them ^[1]. Still, the litigation could change where compounded semaglutide is sold in some states, and people who currently fill prescriptions through a compounding pharmacy or telehealth service may find their options shift. Which sellers are affected by the new filings has not been disclosed ^[1].

Novo Nordisk says the ingredient supply chain is the central safety question, and its position is that compounded products are not interchangeable with its approved medicines ^[1]. Independent confirmation of the company's characterization of specific products is not included in the announcement, and the outcome of the new cases has not been reported ^[1].

What happens next

No hearing dates, defendant names, or court locations for the 14 new cases have been disclosed ^[1]. Novo Nordisk says it will keep pursuing education, advocacy, and legal action and is urging regulators to enforce existing laws ^[1]. The FDA alert from July 29 remains the agency's most recent warning cited in the announcement ^[1].