Mylan Challenges Novo Nordisk's Wegovy Patent as Danish Drugmaker Bets Billions on Life After Semaglutide

Mylan seeks a declaratory judgment that its planned generic Wegovy does not infringe a Novo Nordisk injection-pen patent, as Novo braces for 2031 US patent losses.

Novo Nordisk's blockbuster obesity franchise has drawn fresh legal fire. Viatris, through its subsidiary Mylan Pharmaceuticals, filed suit in a US federal court in Delaware on Thursday, seeking a declaratory judgment that its planned generic version of Wegovy does not infringe a Novo Nordisk patent. The patent at issue covers delivery of the drug via single-dose injection pens — the very hardware that has helped make Wegovy a household name.

By moving early, Mylan hopes to clear regulatory and intellectual-property hurdles before a generic can reach the market. The challenge lands as Novo Nordisk's obesity and diabetes portfolio, anchored by Wegovy and related treatments, faces mounting attention from copycat manufacturers and rivals in the fast-expanding GLP-1 sector.

A Patent Cliff Looming in 2031

The Delaware case arrives at a delicate moment for the Danish group. CEO Mike Doustdar said Monday that key obesity and diabetes medicines lose US patent protection in 2031, forcing the company to line up replacements well in advance. Novo Nordisk intends to launch more than five new blockbuster drugs by 2030 to offset the revenue that will eventually erode.

Doustdar is placing a large share of that wager on next-generation treatments and alternative delivery methods. Oral obesity pills, he reckons, could account for as much as half the global market for weight-loss therapies by 2030 — a shift he believes plays to Novo Nordisk's strengths, since competitors have concentrated heavily on injectables.

Deal Spree Targets Long-Acting Shots and Oral Therapies

The company has been spending aggressively to build that future. On Wednesday it signed a global licensing agreement with Nanexa worth up to roughly EUR 1.17 billion, or as much as USD 1.33 billion, aimed at long-acting injectable medicines for obesity, type 2 diabetes and other cardiometabolic conditions. Days earlier, on September 17, it struck a research and licensing partnership with Orbis Medicines valued at up to USD 1.4 billion to develop oral therapies, alongside a strategic equity stake in Orbis whose financial terms were not disclosed.

Novo Nordisk is also reaching for artificial intelligence to speed up its research cycles. A September 16 collaboration with Anthropic will see Claude models deployed in drug discovery and software development.

CagriSema Data Underpin the Pipeline Story

Central to the company's hopes is CagriSema, which posted fresh clinical results on Monday. In a late-stage diabetes trial, the combination delivered an average weight loss of 12.4 percent, beating a 5 mg dose of Eli Lilly's tirzepatide at the doses tested. A separate late-stage obesity study showed a 21 percent reduction in weight versus placebo.

On the strength of that data, management aims to bring more than five new blockbuster medicines to market by 2030, targeting additional pipeline revenue exceeding DKK 150 billion by 2035. Executives say the balance sheet is sturdy enough to fund larger acquisitions if the right opportunity arises.

Analysts Want Proof, Not Promises

The market has yet to be convinced. At a capital markets day in recent days, BMO analyst Evan Seigerman noted that a projected revenue growth rate of 3.6 percent is already baked into the share price, leaving management to prove it can execute. Doustdar himself urged staff on September 15 to adopt a more customer-focused culture and win back ground lost to Eli Lilly, while fielding tougher questions about the company's pricing power.

The cost of the licensing spree adds another layer of risk. Sums such as the potential EUR 1.17 billion for Nanexa flow into projects whose commercial payoff may not be known for years, and setbacks in clinical phases or regulatory delays could quickly undermine the optimistic revenue targets.

Shares Steady After Legal News, but the Year Has Been Bruising

Investors took the Mylan lawsuit in stride. Novo Nordisk stock closed Friday at EUR 34.05, up 0.2 percent on the day. Even so, the shares have slid 23 percent since the start of the year and sit 38 percent below their 52-week high — a reflection of investor unease over intensifying competition and the durability of the company's patent protection.

For shareholders, the question now is whether the current weakness marks a buying opportunity or the start of a longer slump. As long as CagriSema and other pipeline candidates progress on schedule and the company retains the financial room for strategic deals, a re-rating remains plausible. Should confidence in the long-term pipeline forecasts falter, or competition force deeper price concessions, further declines are on the table. Much will hinge on whether Novo Nordisk can convert its Nanexa and Orbis partnerships into tangible clinical advances — making the next round of trial and approval updates the ones to watch.