Novo Nordisk’s One-Two Punch: FDA Curbs Copycats as Oral Ozempic Hits 70,000 Pharmacies

Novo Nordisk gains 6% as FDA targets cheap semaglutide copies and launches first oral GLP-1 tablet in the US, but stock remains 49% below highs amid generic competition.

The Danish drugmaker is staging a comeback on two fronts. Within 48 hours, the US Food and Drug Administration moved to choke off cheap compounded versions of semaglutide, while Novo Nordisk launched the first-ever oral GLP-1 tablet across America. The twin developments sent shares climbing roughly 6% on the FDA news alone, snapping a prolonged slump that had wiped more than 40% off the stock over the past year.

FDA Takes Aim at Compounding Loophole

On May 1, the FDA proposed removing semaglutide from the 503B bulk substances list — a designation that had allowed outsourcing facilities to mass-produce copycat versions of Ozempic and Wegovy during supply shortages. The agency now argues those shortages no longer justify the exception. The public comment period runs until June 29, but the writing is already on the wall for compounders like Hims & Hers, whose low-cost alternatives have eroded Novo Nordisk’s pricing power.

Hims & Hers downplayed the immediate impact, but the medium-term threat is unmistakable. For Novo Nordisk, the move shores up its monopoly on the active ingredient just as it rolls out a new delivery format designed to expand the patient pool.

Oral Ozempic: A Tablet for the Masses

The very next day, Novo Nordisk began shipping oral Ozempic to more than 70,000 US pharmacies. Available in three dosages, it is the first FDA-approved oral GLP-1 drug cleared to reduce cardiovascular risk in type 2 diabetes patients. The pricing strategy is aggressive: insured patients pay as little as $25 per month, while self-pay patients can access the starter dose for roughly $149 monthly through the NovoCare platform — significantly cheaper than injectable alternatives.

To turbocharge adoption, the company has inked distribution deals with WW International and the discount platform GoodRx. The goal is seamless access from day one, converting patients who might have balked at needles or high out-of-pocket costs.

Stock Still Nursing Deep Wounds

Despite the recent bounce, the recovery is fragile. At around €36 per share, Novo Nordisk trades nearly 49% below its 52-week high. The relative strength index sits at 23 — deep in oversold territory — underscoring just how battered investor sentiment had become. Bank of America sees 30% or more upside potential from upcoming clinical and regulatory milestones, but that would still leave the stock well short of its former peak.

On a weekly basis, shares have gained roughly 2% to 7%, depending on the listing, though the year-to-date picture remains negative at around 14% in the red. A DKK 15 billion share buyback program is providing additional support.

Not All Clear Sails: Generic Competition Emerges

The FDA’s compounding crackdown is a welcome reprieve, but Novo Nordisk faces a new headache north of the border. Canada became the first G7 country to approve generic semaglutide after the local patent expired in early January 2026. Dr. Reddy’s Laboratories and Apotex both received approvals in late April and early May, opening the door to cheaper alternatives in a developed market.

Scientific Validation and Q1 Earnings Ahead

The GLP-1 class continues to rack up evidence. A meta-analysis from Anglia Ruskin University, published May 1 and covering roughly 90,000 patients, found that GLP-1 agonists cut the risk of major adverse cardiovascular events by about 13% — regardless of whether patients had diabetes. That broadens the potential addressable market beyond weight loss and glucose control.

Investors now turn to Wednesday, May 6, when Novo Nordisk reports first-quarter results. The consensus calls for earnings of $0.87 per share on revenue of $11.35 billion. A strong print would provide the fundamental validation the stock needs to sustain its nascent recovery.