The Hims lawsuit picture actually involves three separate matters: a patent infringement suit that Novo Nordisk filed against Hims & Hers in February 2026 and dismissed a month later, a securities fraud class action still pending in federal court in California, and a Department of Justice referral over the company’s compounded GLP-1 sales. FDA enforcement, including a formal warning letter, sits alongside them.
Novo Nordisk’s Patent Infringement Suit
Novo Nordisk filed suit against Hims & Hers Health, Inc. and Hims, Inc. on February 9, 2026, in the U.S. District Court for the District of Delaware (Case No. 1:26-cv-00143-CFC). The case centered on U.S. Patent No. 8,129,343, titled “Acylated GLP-1 Compounds,” which covers semaglutide and pharmaceutical compositions containing it.1STAT News. Novo Nordisk v. Hims & Hers Complaint
Novo alleged direct infringement under 35 U.S.C. § 271(a), pointing to Hims products marketed as “Compounded GLP-1,” “Compounded GLP-1 Microdose,” and “Compounded GLP-1 Pill,” none of which had been reviewed or approved by the FDA. The complaint also alleged induced infringement under § 271(b), asserting that Hims knowingly encouraged customers to use the products. According to Novo, Hims had been aware of the patent since at least 2024 and received an explicit notice letter on February 8, 2026.2The FDA Law Blog. Novo Nordisk v. Hims & Hers Complaint
The patent, filed in 2006 and issued in 2012, has a base expiration in 2026 but was granted a 1,046-day patent term adjustment extending protection to roughly January 2029. Novo has applied for a further extension that could push expiration to December 2031.3Regulations.gov. Patent Term Extension Application for U.S. Patent No. 8,129,343
The case did not last. On March 9, 2026, Novo filed a notice of voluntary dismissal, and the docket closed the same day.4CourtListener. Novo Nordisk A/S v. Hims & Hers Health, Inc. The dismissal was without prejudice, meaning Novo can refile. Novo CEO Mike Doustdar told CNBC, “We have decided to drop the current court proceedings and, of course, we reserve to bring that back if need be.”5CNBC. Novo Nordisk Ends Legal Proceedings With Hims & Hers Over Compounded Weight Loss Drugs
The dismissal accompanied a new commercial deal. Hims agreed to sell Novo’s branded Ozempic (0.5 mg, 1 mg, and 2 mg injections) and Wegovy (injections and tablets in multiple doses) through its platform at the same self-pay prices offered on other telehealth services, to stop advertising compounded GLP-1 products, and to offer them only on a “limited scale” where a provider determined a compounded product was clinically necessary for a patient whose needs could not be met by available FDA-approved treatments.6Pharmaceutical Technology. Novo and Hims & Hers Become Partners to End Legal Feud Hims stock rose more than 40% on the morning of the announcement.5CNBC. Novo Nordisk Ends Legal Proceedings With Hims & Hers Over Compounded Weight Loss Drugs
The Securities Class Action
The other active case is a securities fraud suit filed by investors. On June 25, 2025, a shareholder filed Sookdeo v. Hims & Hers Health, Inc. (Case No. 3:25-cv-05315) in the U.S. District Court for the Northern District of California, naming the company along with CEO Andrew Dudum and CFO Oluyemi Okupe.7Kehoe Law Firm. Sookdeo v. Hims & Hers Health Class Action Complaint
The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5. During the proposed class period of April 29 through June 22, 2025, investors say, executives promoted a partnership with Novo Nordisk while allegedly failing to disclose that Hims was engaged in deceptive promotion and the sale of knockoff versions of Wegovy, and that there was a substantial risk Novo would terminate the collaboration.8Levi & Korsinsky. Hims & Hers Health Securities Class Action Lawsuit The lead plaintiff deadline was August 25, 2025.
The share-price move that anchors the damages theory happened on June 23, 2025, the day Novo terminated the partnership. Hims stock fell 34.6%, from $64.22 to $41.98, erasing roughly $5 billion in market value.8Levi & Korsinsky. Hims & Hers Health Securities Class Action Lawsuit The case remains pending, with no class certified.
FDA Warning Letter and DOJ Referral
The FDA opened its own track. Inspectors visited MedisourceRx, the compounding pharmacy Hims acquired in September 2024, in May and June 2025 and reported what the agency called “troubling problems,” including pest contamination and a failure to report a serious adverse event within the required 15-day window. In January 2025, a patient had been hospitalized for three nights with severe stomach issues after taking a compounded injectable drug from the facility.9STAT News. FDA Inspection Warns Hims Compounder Over Bugs, Wegovy
On September 9, 2025, the FDA issued Warning Letter 716567 to Hims & Hers, citing misbranding violations in the company’s marketing of compounded semaglutide. The agency singled out claims such as “Same active ingredient as Ozempic and Wegovy” and “Clinically proven ingredients” as false or misleading, noting that compounded drugs are not FDA-approved and that such language improperly implies equivalence with approved products. The FDA stated the letter was not an “exhaustive list” of violations.10U.S. Food and Drug Administration. Warning Letter: Hims & Hers Health Inc.
Enforcement escalated in February 2026 after Hims announced, on February 5, plans to launch a compounded Wegovy pill at $49 per month.11Fox Business. Hims & Hers Responds to FDA Pressure, Pulls Knockoff Wegovy Drug Launch FDA Commissioner Martin Makary threatened “swift action” the same day, and on February 6 the FDA said it would take “decisive steps” to restrict active pharmaceutical ingredients used in mass-marketed compounded GLP-1 drugs, naming Hims specifically.12U.S. Food and Drug Administration. FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs The Department of Health and Human Services referred Hims to the Department of Justice for investigation of potential violations of the Federal Food, Drug, and Cosmetic Act. Hims withdrew the pill on February 7.13BioPharma Dive. Hims Stops Launch of Compounded Wegovy After FDA, Novo Pressure
No public charges or statements have emerged from the DOJ referral in the available reporting.
Why Novo Terminated the First Partnership
The events that seeded both the patent suit and the shareholder case trace back to the collapse of an earlier Novo–Hims collaboration. After the FDA declared the semaglutide injection shortage resolved on February 21, 2025, Novo began working with select telehealth companies to move patients from compounded versions onto branded Wegovy through its NovoCare Pharmacy. Hims was among them.14Novo Nordisk. Novo Nordisk Terminates Collaboration With Hims & Hers Health
The arrangement lasted roughly a month. On June 23, 2025, Novo publicly ended it, accusing Hims of “illegal mass compounding” and “deceptive marketing.” Novo said Hims had failed to comply with laws prohibiting mass sales of compounded drugs “under the false guise of ‘personalization'” and that the active ingredients in the company’s compounded products came from Chinese suppliers whose manufacturing had never been authorized or inspected by the FDA.15CBS News. Novo Nordisk, Hims & Hers Wegovy Weight Loss Drugs
Hims CEO Andrew Dudum responded the same day on social media, accusing Novo’s management of “misleading the public.” He later told the Washington Post he had been “blindsided” and described the breakup as a “short-lived marriage,” alleging that Novo’s commercial team had pressured Hims to steer patients toward Wegovy regardless of clinical necessity, which he called “anticompetitive.” Hims maintained that its compounded products met “all applicable regulatory requirements.”16The Washington Post. Hims & Hers Novo Nordisk Partnership
What’s Still Open
Three threads remain live. The Sookdeo securities class action is ongoing in the Northern District of California, with no class certified. The DOJ investigation referred by HHS in February 2026 has not produced any public action. And although the Novo patent suit was dismissed, it was dismissed without prejudice, and Novo has explicitly reserved the right to bring it back if the new commercial relationship falters. The first Novo–Hims partnership lasted about a month before ending in accusation and litigation, so the durability of the second one is an open question.