Hims & Hers pulls copycat Wegovy pill amid legal action

The basics:

• Hims & Hers pauses compounded semaglutide pill rollout
• Novo Nordisk sues over alleged GLP-1 patent infringement
• FDA warns against non-approved compounded weight loss drugs
• Lawsuit seeks permanent ban and damages against Hims & Hers

Hims & Hers reversed course on its launch of a cheaper, copycat version of Novo Nordisk’s GLP-1 weight loss pill amid legal action.

In a Feb. 7 social media post, the San Francisco-based telehealth platform said, “Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment.”

Hims & Hers unveiled plans two days prior to begin offering compounded copies of the Wegovy pill for an introductory price of $49 per month and $99 thereafter with a five-month plan.

Despite this weekend’s announcement, Novo Nordisk has filed a lawsuit against Hims & Hers claiming the company’s compounded products in the U.S. infringe on its patent for semaglutide.

The Danish drugmaker previously threatened legal action last week, hours after Hims & Hers began promoting compounded GLP-1 pills.

In a lawsuit filed Feb. 9, Novo Nordisk took aim at Hims & Hers’ injectable compounded semaglutide products.

Permanent ban

Up until last month, the blockbuster medication was only available as an injection. A once-daily oral version hit the market in January as the first and only FDA-approved pill for weight loss.

Semaglutide, the active ingredient in GLP-1 drugs, is protected in the U.S. until 2032. Besides Wegovy, Novo Nordisk has two other semaglutide medications: once-weekly injectable Ozempic for type 2 diabetes and once-daily oral treatment Rybelsus for type 2 diabetes.

Filed in U.S. District Court for the District of Delaware, the lawsuit is asking that Hims & Hers be permanently banned from selling unapproved, compounded drugs that infringe on Novo Nordisk patents. It is also seeking damages.

Novo Nordisk accused Hims & Hers of engaging in “promotional campaigns that highlight its compounded semaglutide products, duping consumers and health care professionals as to the clinical benefits and safety of these unapproved drugs.” The company has its U.S. headquarters in Plainsboro.

“Hims continues to unlawfully mass compound injectable versions, made with inauthentic API [active pharmaceutical ingredients] and these knock-offs are putting patient health and wellbeing at risk,” the company said.

FDA concerns

The U.S. Food and Drug Administration has also said it would take action against Hims & Hers.

In a Feb. 6 press release, the agency said it plans to restrict GLP-1 ingredients used in non-approved compounded drugs that companies like Hims & Hers have marketed as authorized treatments. The FDA cited concerns over quality, safety and potential violations of federal law.

FDA Commissioner Marty Makary vowed “swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.”

“The FDA cannot verify the quality, safety or effectiveness of non-approved drugs,” he shared in a social media post.

The FDA cannot verify the quality, safety or effectiveness of non-approved drugs.
– Marty Makary, FDA commissioner

Additionally, U.S. Department of Health and Human Services General Counsel Mike Stuart said he referred Hims & Hers to the Department of Justice for an investigation over potential violations.

Under the Federal Food, Drug and Cosmetic Act, compounding pharmacies can make and sell large quantities of brand-name medicines only if they are in short supply. When the FDA declared a semaglutide shortage in 2022, pharmacies, telehealth companies and other health care providers could manufacture copycat GLP-1 therapies. Because consumers considered the drugs a cheaper, easier to access alternative, interest in compounded treatments skyrocketed.

Last year, the FDA removed semaglutide from its shortage list and told compounding pharmacies to stop producing unbranded versions.

The agency continues to allow compounding of prescriptions specific to particular patients. In those instances, pharmacies cannot produce the dugs in large batches that might allow for cheaper production costs.

‘Dangerous and deceptive to patients’

Novo Nordisk has since filed over 120 lawsuits to stop the marketing and sale of copycat GLP-1s. The complaints have led to injunctions and court orders blocking unapproved sales; protecting the company’s patents; and limiting distribution of unsafe, non FDA-approved semaglutide.

Commenting on the complaint against Hims & Hers, Novo Nordisk Senior Vice President, Group General Counsel, Global Legal, IP and Security John Kuckelman said, “Throughout Novo Nordisk’s 103-year-long history, patient safety has always been our top priority. Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA’s gold standard review process – that’s dangerous and deceptive to patients, and undermines the scientific innovation and regulatory rigor in place to ensure these treatments are safe and effective.”

“We’ve taken legal action to protect the American public and our intellectual property and will continue to work with regulators, law enforcement, and other key stakeholders to ensure patients have access to FDA approved safe and effective medicines,” he said.

According to Novo Nordisk’s testing, injectable semaglutide drugs compounded by pharmacies were found to contain impurities of up to 86%, with compounded oral semaglutide drugs containing impurities as high as 75%. Even in small quantities, such impurities can negatively impact the safety and efficacy of a drug product, including unwanted immune responses like anaphylactic shock, the company said.

‘Blatant attack’

A spokesperson for Hims & Hers told NJBIZ, “Novo Nordisk’s lawsuit is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care. Once again, Big Pharma is weaponizing the US judicial system to limit consumer choice.

“This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer,” the representative continued. “Hims & Hers has a long history of providing safe access to personalized healthcare to millions of Americans, and we will continue to fight to provide choice, affordability, and access.”

Once again, Big Pharma is weaponizing the US judicial system to limit consumer choice.
– Hims & Hers representative

Fierce Pharma noted that since the Wegovy pill is one of the first offerings on the TrumpRx.gov platform the federal government “may be further encouraged to direct patients toward” the branded version. The recently launched, government-run website is aims to help Americans access discounted prescription drugs by connecting users with manufacturers’ direct-to-consumer purchasing pages and pharmacy coupon offers.