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    1. Home
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    3. >Novo Nordisk sues Hims after $49 weight-loss pill sparks FDA backlash
    Finance

    Novo Nordisk Sues Hims After $49 Weight-Loss Pill Sparks Fda Backlash

    Published by Global Banking & Finance Review®

    Posted on February 9, 2026

    4 min read

    Last updated: February 9, 2026

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    Quick Summary

    Novo Nordisk shares rose 4.5% after Hims canceled its $49 weight-loss pill due to legal and FDA pressures. Novo faces competition and pricing challenges.

    Novo Nordisk Files Lawsuit Against Hims Over Weight-Loss Pill Controversy

    Legal Dispute Over Weight-Loss Medications

    By Stine Jacobsen and Maggie Fick

    COPENHAGEN, Feb 9 (Reuters) - Novo Nordisk sued Hims and Hers Health on Monday over patent infringement after the U.S. telehealth firm launched, then cancelled, a $49 copy of Novo's weight-loss pill Wegovy following a swift backlash from U.S. authorities.

    Novo's shares jumped nearly 6% on Monday, while Hims sank 25% in morning trading. Shares of Novo and rival Eli Lilly had tumbled last week after Hims introduced the cut-price pill, which had looked set to erode Novo's takings and jeopardise its shift towards a cash-pay consumer market.

    Background of the Lawsuit

    The lawsuit, which covers Novo's weight-loss drugs in pill and injectable forms, highlights the friction between obesity drugmakers and pharmacies that mix the active ingredients, harming the earnings of the original drug manufacturers.

    Impact on Stock Prices

    "There is now a growing chorus of parties that have said, enough is enough on the compounding situation in the United States," Novo Nordisk's general counsel John Kuckelman told Reuters, adding that Hims' pill launch was a "tipping point."

    The lawsuit, Hims said, was a "blatant attack" by Novo on "millions of Americans who rely on compounded medications for access to personalized care."

    "Once again, Big Pharma is weaponizing the U.S. judicial system to limit consumer choice," it said.

    'WAR ON GLP-1 COMPOUNDERS IN GENERAL'

    FDA's Role in the Controversy

    Analysts said the lawsuit and the unusually rapid U.S. Food and Drug Administration response could mark a broader crackdown on compounded GLP-1, potentially easing competition on the big manufacturers' patented weight-loss treatments.

    "They are not only declaring war on Hims & Hers' Wegovy pill, but GLP-1 (compounders) in general," said Sydbank analyst Soren Lontoft Hansen.

    Novo said it was "asking the court to permanently ban Hims from selling unapproved, compounded drugs that infringe our patents, and is seeking to recover damages."

    U.S. regulations have allowed compounding pharmacies to make and sell some brand-name medicines if they are in short supply. Without a shortage, however, compounding is only allowed in the U.S. when the drug is personalized for a patient, for example, at doses not available in the branded medicines.

    NOVO, LILLY STRUCK PRICING DEALS WITH TRUMP

    Hims, whose pill was based on semaglutide - the active ingredient in Novo Nordisk's blockbuster drugs Wegovy and Ozempic - said on Saturday it would stop offering the treatment.

    Novo and Lilly struck high-profile pricing deals with U.S. President Donald Trump last year and their weight-loss drugs are prominent on the new TrumpRx discounted-drugs website.

    "I think the FDA made it quite clear that they would not tolerate a compounded Wegovy pill. This was an attack on the authority of the FDA," said Markus Manns at Novo and Lilly shareholder Union Investment.

    Lilly's shares, already near record highs, were up about 1%.

    RARE VICTORY FOR NOVO AS IT FIGHTS COMPOUNDED DRUGS

    The FDA said on Friday it would restrict GLP-1 ingredients used in non-approved compounded drugs, helping revive Novo's shares.

    Still, intense competition continues in the rapidly shifting GLP-1 market as Eli Lilly and compounding pharmacies offer injectable versions of semaglutide.

    Novo Nordisk's market value is down nearly 50% over the past year. Its stock sank 17% in a day last week after it flagged "unprecedented price pressure."

    Despite pioneering the obesity drug market, the recent setbacks show how quickly Novo's dominance has eroded. And with Eli Lilly's oral GLP-1 pill orforglipron expected to receive FDA approval in April, competition is set to intensify.

    In the key U.S. market, the obesity drugs made by Novo Nordisk and Lilly are driving a shift to a consumer-focused market in which drugmakers are looking toward cash-pay channels and telehealth to reach tens of millions of Americans. 

    (Reporting by Stine Jacobsen and Louise Rasmussen in Copenhagen, Maggie Fick in London; Writing by Adam Jourdan; Editing by Joe Bavier and Bernadette Baum)

    Table of Contents

    • Legal Dispute Over Weight-Loss Medications
    • Background of the Lawsuit
    • Impact on Stock Prices
    • FDA's Role in the Controversy

    Key Takeaways

    • •Novo Nordisk shares rose 4.5% after Hims canceled its weight-loss pill.
    • •Hims' pill used semaglutide, a key ingredient in Novo's drugs.
    • •FDA crackdown on unauthorized medications influenced the decision.
    • •Novo faces competition from Eli Lilly and cheaper alternatives.
    • •Novo's market value has significantly decreased since June 2024.

    Frequently Asked Questions about Novo Nordisk sues Hims after $49 weight-loss pill sparks FDA backlash

    1What is the main topic?

    The article discusses Novo Nordisk's share increase following Hims' cancellation of a weight-loss pill due to legal and FDA pressures.

    2Why did Hims cancel the weight-loss pill?

    Hims canceled the pill after legal threats from Novo Nordisk and the FDA's crackdown on unauthorized medications.

    3What challenges does Novo Nordisk face?

    Novo Nordisk faces competition from Eli Lilly and pricing pressures from cheaper alternatives.

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