Novo Nordisk Launches Wegovy Pill, Sues Compounding Firms Over Patent Infringement
Novo Nordisk secured FDA approval for oral Wegovy tablets in December 2025 and subsequently sued telehealth company Hims & Hers for patent infringement over compounded versions. The company is the only manufacturer with an FDA-approved GLP-1 weight loss pill.
In December 2025, the Food and Drug Administration approved Wegovy (semaglutide) as an oral tablet, making Novo Nordisk the only company to gain FDA approval for a GLP-1 weight loss pill. The approval gives Novo an exclusive window to sell the pill to consumers who want to lose weight without using an injectable version of the medication.
Novo Nordisk sued Hims & Hers on Feb. 9, alleging the telehealth company infringed on Novo's patent by selling versions of Wegovy. The lawsuit came less than one week after Hims & Hers announced plans to sell a compounded version of Wegovy at an introductory price of $49 per month. Days later, after the FDA threatened action against Hims & Hers, the company dropped its plans.
Novo Nordisk officials said Hims & Hers announcement to launch a pill version of Wegovy was the final straw. Unlike the injectable versions, there was never a shortage of the Wegovy pill and no need to market a compounded version, Novo Nordisk officials said.
Both Wegovy injections and tablets contain the same active ingredient, semaglutide. Both forms of Wegovy are FDA-approved for managing body weight in adults with obesity or overweight and reducing the risk of major heart events in certain adults with heart disease and obesity or overweight. Unlike the injections, the Wegovy tablet is not approved for weight management in children ages 12 or older, or for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
The Wegovy injection is administered via self-injector pen or injection by a healthcare professional, once weekly. The tablet is taken orally, once daily, with a gradual dose increase until a 25 mg daily maintenance dose is reached. At their full maintenance doses, average semaglutide levels in the body are similar between the Wegovy 25 mg daily tablet and the 2.4 mg weekly injection in adults.
During an earnings conference call with investors in February, Novo executives stressed the importance of a fast launch for the company's oral medications. They said more than 50,000 weekly prescriptions of oral Wegovy were being filled. And 9 in 10 consumers who filled prescriptions in the opening weeks paid with cash. The starting price for the Wegovy pill is $149, or about $200 less than injectable version of the medication.
Novo won't have this exclusive sales opportunity forever. Eli Lilly's weight-loss pill, orforglipron, could gain FDA approval in April.
About 1 in 8 Americans take a GLP-1 drug for weight loss, diabetes or other conditions, according to KFF, a health policy nonprofit. And many customers whose insurance plans don't cover the medications struggle to afford these drugs. Those compounded drugs were only supposed to be broadly offered while the popular brand-name drugs were in shortage. The Food and Drug Administration declared the shortage over in 2025, yet telehealth companies still sell compounded versions of the anti-obesity drugs, tailoring the medications to different dosages and often selling them for less than what pharmaceutical companies charge for the brand-name drugs.
Hims & Hers officials said in a statement that treating obesity requires "precision and personalization." The company still sells injectable GLP-1 medications. Hims & Hers said it has about 2.5 million subscribers across all of its health offerings. GLP-1 customers represent a "small minority" of its subscriber base, the company said.
Novo Nordisk and Eli Lilly have cut prices for consumers whose insurance plans don't cover these medications. These cash-paying customers can buy Wegovy or Zepbound from the pharmaceutical companies, telehealth portals, retailers such as Costco and Sam's Club or TrumpRx, the Trump administration's direct-to-consumer drug sales website. A survey by benefits consultant Mercer found 49% of large employers covered GLP-1 medications in 2025.
In Europe, the European Commission approved a new 7.2 mg weekly maintenance dose of Wegovy for adults dealing with obesity. The approval stemmed from a favorable evaluation by the European Medicines Agency's scientific committee on December 12, 2025. Now that the 7.2 mg dosage has been approved, physicians in the European Union can prescribe it as three 2.4 mg injections during a single weekly session. Novo Nordisk is also in the process of seeking approval for a single-dose 7.2 mg pen in the EU, which might become available within the year if sanctioned. This dosage is intended to be used by patients who have been on the 2.4 mg dose for at least four weeks and need further weight loss while maintaining muscle mass. The 7.2 mg version of Wegovy is already accessible in the UK, and Novo Nordisk is awaiting regulatory decisions from the US Food and Drug Administration and several other countries.