Ozempic Legal & Patent Challenges: FDA Approval, Label History, and Safety Litigation

When was Ozempic approved, and what does the label cover now?

Ozempic injection was approved on December 5, 2017 under NDA 209637 [1]. Semaglutide is also FDA-approved under other applications: Rybelsus oral tablets, approved September 20, 2019 under NDA 213051; Wegovy injection, approved June 4, 2021 under NDA 215256; and Wegovy tablets, approved December 22, 2025 under NDA 218316 [6][7][8]. Ozempic-branded tablets (1.5, 4 and 9 mg) sit under the Rybelsus application rather than the injection application [7].

The label effective June 1, 2026 lists three indications: an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes; reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease; and reducing the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease [2].

There is no weight-loss indication on the Ozempic label, which belongs to Wegovy, and the label says safety and efficacy in pediatric patients have not been established [2]. The label's schedule for the once-weekly injection is 0.25 mg for 4 weeks as a starting dose that is not a maintenance dose, then 0.5 mg, with maintenance at 0.5, 1 or 2 mg and a maximum of 2 mg weekly [2].

Which label revisions and safety reviews matter?

FDA's approval record for NDA 209637 lists each supplement by date and review category [1].

A supplement dated March 28, 2022 is classified as a new dosing regimen [1]. The current label permits a maximum of 2 mg once weekly, reached after at least 4 weeks on 1 mg [2]. A supplement dated January 28, 2025 is classified as a new indication, and the current label includes the kidney outcome indication [1][2]. The FLOW trial tested semaglutide 1 mg weekly in 3,533 adults with type 2 diabetes and chronic kidney disease and was stopped early at an interim analysis. The composite of kidney failure, 50% or greater eGFR decline, or kidney or cardiovascular death occurred in 331 of 1,767 people on semaglutide and 410 of 1,766 on placebo (hazard ratio 0.76) [9].

The current Ozempic injection label contains no suicidal behavior or ideation warning [2].

EMA's safety committee concluded on June 6, 2025 that NAION (non-arteritic anterior ischemic optic neuropathy) is a very rare side effect of semaglutide, meaning up to 1 in 10,000 people. That corresponds to roughly one extra case per 10,000 person-years, about a two-fold relative risk in large studies of adults with type 2 diabetes. EMA advised that treatment be stopped if NAION is confirmed [3]. The current US Ozempic label does not mention NAION; it only advises monitoring people with a history of diabetic retinopathy [2].

What did the compounding fight actually settle?

The challenge came in Outsourcing Facilities Association v. FDA, No. 4:25-cv-00174 (N.D. Tex.). On April 24, 2025 the district court denied the plaintiffs' preliminary injunction motion [4]. For state-licensed pharmacies and physicians compounding semaglutide injection, the period of enforcement discretion ended at that point. For outsourcing facilities, FDA said it would not act on violations that depended on the earlier shortage-era conditions until May 22, 2025 [4].

What remains allowed is narrower. A state-licensed pharmacy may compound for an individual patient on a prescription. A product that is essentially a copy of an approved drug is allowed only if it is made rarely (FDA says it does not intend to act against four or fewer such prescriptions per calendar month) or if the prescriber documents a significant difference for that patient [4]. Adding another ingredient does not automatically avoid that rule: FDA says a semaglutide-plus-vitamin-B12 product given by the same route, with each strength within 10% of the commercial product, may still count as essentially a copy [4]. Outsourcing facilities generally cannot compound from bulk substances unless the substance is on FDA's bulks list, and FDA says semaglutide is not on it [4].

On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the bulks list, finding no clinical need for outsourcing facilities to compound them from bulk substances. Comments were due June 29, 2026, and FDA says no final decision has been made [10].

What does FDA say about compounded semaglutide now?

FDA says compounded drugs are not FDA approved and are not reviewed for safety, effectiveness or quality before marketing [5]. As of May 31, 2026, FDA had received 990 adverse event reports for compounded semaglutide and says this likely undercounts [5]. FDA reports dosing errors with compounded injectable semaglutide, including patients measuring the wrong dose, clinicians miscalculating, and doses above the label [5]. It also says semaglutide sodium and semaglutide acetate are different active ingredients from the approved drug, and that it knows of no lawful basis for using them in compounding [5].

Which safety findings are in the current Ozempic label?

The boxed warning says semaglutide caused dose- and duration-dependent thyroid C-cell tumors in rodents at clinically relevant exposures. Whether it does so in humans is unknown, and the drug is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2 [2].

Other label content:

• Acute pancreatitis has been observed with GLP-1 receptor agonists including Ozempic, and the label says to discontinue if pancreatitis is suspected [2].
• The label says Ozempic is not recommended in patients with severe gastroparesis, as part of its severe gastrointestinal warning; it does not state that semaglutide causes gastroparesis [2]. Postmarketing reports listed in the label include ileus, intestinal obstruction and severe constipation with fecal impaction [2].
• For gallbladder disease, the label says that if cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated [2].
• For pulmonary aspiration during general anesthesia or deep sedation, the label instructs patients to inform healthcare providers of any planned surgeries or procedures [2].
• The label says hypoglycemia risk rises when Ozempic is combined with insulin or a sulfonylurea, and that reducing the dose of the other drug may be necessary [2].