Novo Nordisk Deploys Licensed Semaglutide Copy in South Africa While Waging Legal War on Two Fronts
Published on 07/27/2026 at 08:41 | Redaktion boerse-global.de
The Danish drugmaker is fighting for its GLP-1 franchise on multiple fronts — from the courtroom to the pharmacy shelf. On Monday, Novo Nordisk began selling an authorized copy of its own blockbuster semaglutide in South Africa, a strategic gambit aimed at undercutting the gray market for unapproved weight-loss and diabetes drugs in emerging economies. The product isn't a cheap knockoff: it uses the same active ingredient, the same manufacturing process, and the same injection pens as the original Ozempic.
Novo Nordisk has partnered with Acino, a subsidiary of Arcera, to distribute the product. South Africa's drug regulator, SAHPRA, has already registered the authorized copy, confirming it meets the same safety and efficacy standards as the branded version. The move targets a persistent problem in many developing markets, where unlicensed copycat drugs and gray-market supplies thrive on the soaring demand for type-2 diabetes treatments. By offering a legal, lower-cost alternative, Novo Nordisk hopes to drain demand from the black market while expanding patient access.
The South African launch arrives amid a flurry of regulatory wins for the company. On July 15, the European Commission approved the oral Wegovy tablet, making it the first oral GLP-1 receptor agonist for weight loss in the European Union. At the same time, European regulators greenlit a new, higher-dose Wegovy injection pen containing 7.2 milligrams of the active ingredient. The approval was backed by data from the STEP-UP study, in which obese adults lost an average of roughly 18.8 percent of their body weight over 72 weeks. In a separate OASIS trial, the 25-milligram oral dose delivered a 17 percent weight loss versus 3 percent for placebo.
Legal Offensive Targets Rivals
The regulatory progress runs parallel to an increasingly aggressive legal strategy. On July 21, Novo Nordisk filed a lawsuit against Eli Lilly, accusing the U.S. rival of running television advertisements that make misleading comparisons between Zepbound and Wegovy. The complaint alleges that Lilly relies on outdated clinical data and compares low Wegovy doses with the highest approved Zepbound dose. Novo Nordisk argues that newer studies of high-dose Wegovy show comparable efficacy. It is seeking a permanent injunction to remove the ads, plus damages. Lilly has rejected the allegations and vowed to defend itself. CNBC commentator Jim Cramer publicly advised Novo Nordisk to compete in the market rather than in court.
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This is not Novo Nordisk's only active legal battle. On February 9, the company sued Hims & Hers over what it says are unauthorized compounded copies of semaglutide products. Novo Nordisk points to FDA concerns about the purity and correct dosing of such compounded drugs. When the lawsuit became public, Hims & Hers shares tumbled roughly 16 percent. The Danish group has also taken legal action internationally: a South African court, at Novo Nordisk's request, barred the supplier iDexis from manufacturing compounded semaglutide, and SAHPRA subsequently ordered a recall of the products.
Mixed Analyst Views Amid Market Pressure
The legal and regulatory developments come as analysts remain divided on the stock's outlook. Willow Tree Research initiated coverage with a buy rating and a $68 price target, citing the oral Wegovy formulation, the pipeline including high-dose Wegovy, CagriSema, and Zenagamtide, and the potential to expand the treated obesity market. It flagged competition, pricing pressure, and the 2032 U.S. patent expiry for semaglutide as key risks. A more cautious analyst house rates the stock a hold, pointing to a 10.3 percent year-on-year decline in adjusted revenue, driven by weakness in Ozempic and Rybelsus, and arguing that the pipeline lacks near-term catalysts. Goldman Sachs cut its price target in March from 400 to 260 Danish kroner.
Novo Nordisk has forecast a revenue decline of between 5 and 13 percent for 2026, weighed down by U.S. price cuts, patent expirations, and intensifying competition — particularly from Eli Lilly. The semaglutide patent runs until 2032 in the U.S. and until 2033 in Europe and Japan.
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Stock Finds Footing After Selloff
At the market close on Friday, Novo Nordisk shares stood at €42.85, up 1.19 percent on the day. The stock has recovered more than 41 percent from its March low of €30.25, though it remains roughly 28 percent below its 52-week high of €59.56. The ongoing buyback program has provided structural support: since launching in February, Novo Nordisk has repurchased around 25 million B-shares under a 12-month program with a total envelope of up to 15 billion Danish kroner.
Investors are now looking ahead to August 5, when the company is set to release its half-year results. The focus will be on whether the strong start for oral Wegovy and expanded production capacity can shore up the full-year guidance. With the growth targets for 2026 under more pressure than in prior years, the market is watching closely to see whether Novo Nordisk's combination of authorized generics, regulatory wins, and courtroom battles can defend its GLP-1 fortress.
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