How Long Has Ozempic Been on the Market? A Timeline From 2017 to the Pill

Written by Dr. Sheri Tomas. Updated November 2, 2026.

Ozempic has been on the market for almost nine years. The FDA approved it on December 5, 2017, for adults with type 2 diabetes, and it reached US pharmacies on February 5, 2018, so as of November 2026 it has been sold for about 8 years and 9 months. Europe approved it on February 8, 2018. Since then its label has grown to include heart protection (2020), a 2 mg dose (2022) and kidney protection (2025); the same medicine, semaglutide, has been launched as Rybelsus (2019), Wegovy for weight loss (2021), the Wegovy pill (2025) and Ozempic tablets (2026). It spent two and a half years on the FDA shortage list, from 2022 to February 2025. Medicare's negotiated price of $274 a month and a cut in the list price to $675 both take effect on January 1, 2027, and generic semaglutide is already sold in India and Canada, though not yet in the US. This guide sets out the full timeline with dates and sources.

Novo Nordisk filed for FDA approval on December 5, 2016. An FDA advisory committee reviewed it in October 2017, and the FDA approved Ozempic exactly a year after filing, on December 5, 2017, as a once-weekly injection to improve blood sugar control in adults with type 2 diabetes. Novo launched it in the US on February 5, 2018, in 0.5 mg and 1 mg doses. The European Commission approved it on February 8, 2018. Ozempic has never been approved for weight loss; that is Wegovy's role, as explained in is Ozempic approved for weight loss.

Ozempic belongs to the GLP-1 receptor agonist class, drugs that mimic a gut hormone released after eating. Novo Nordisk's earlier GLP-1 drug, liraglutide, was approved in the US as Victoza in January 2010 and had to be injected daily. Semaglutide was designed as a longer-lasting version: its structure binds to albumin in the blood and resists breakdown, giving a half-life of about a week, which made once-weekly dosing possible. Novo's scientists described its design in the Journal of Medicinal Chemistry in 2015. How the drug works is explained in what is Ozempic, and how the brand names relate to the molecule in Ozempic vs semaglutide.

Approval rested on the SUSTAIN program of clinical trials in type 2 diabetes. The most influential was SUSTAIN-6, presented in September 2016 and published in the New England Journal of Medicine. In 3,297 people with type 2 diabetes at high cardiovascular risk, major cardiovascular events (heart attack, stroke or cardiovascular death) occurred in 6.6% on semaglutide against 8.9% on placebo, a 26% relative reduction. That result later supported Ozempic's heart-protection indication.

Ozempic started with one use and now has three, all in adults with type 2 diabetes. In January 2020 the FDA added a cardiovascular indication based on SUSTAIN-6. In March 2022 it approved a higher 2 mg dose for people who need more blood sugar lowering. In January 2025 it added a kidney indication based on the FLOW trial, which enrolled 3,533 people with type 2 diabetes and chronic kidney disease and found a 24% lower risk of major kidney events and cardiovascular death. How Ozempic is used in diabetes today is covered in Ozempic for diabetes.

All three contain semaglutide. Rybelsus, approved in September 2019, was the first GLP-1 drug that could be swallowed rather than injected. Wegovy, approved in June 2021, uses higher doses of semaglutide for chronic weight management and was the first new weight-management drug in seven years; it later added heart protection and, in 2026, a 7.2 mg dose. A Wegovy pill followed in December 2025, and in early 2026 the FDA approved Ozempic tablets, a reformulated version of Rybelsus sold under the Ozempic name. The injection and pill forms are compared in Ozempic tablets, and the two injectable brands in Ozempic vs Wegovy.

Demand for semaglutide, driven partly by off-label use for weight loss, outstripped supply. Wegovy entered the FDA's shortage list in March 2022 and Ozempic in August 2022. During the shortage, federal rules allowed pharmacies to make compounded copies, which became widely sold online. The FDA declared the shortage resolved on February 21, 2025, and the temporary allowance for compounders ended in the spring of 2025. Why compounded semaglutide is not the same as Ozempic is explained in compounded semaglutide vs Ozempic.

Ozempic launched at a price similar to competing weekly GLP-1 drugs. In January 2025 Medicare chose semaglutide for its drug price negotiation program, and in November 2025 it announced a negotiated price of $274 for a 30-day supply, about 71% below the 2024 list price, effective January 1, 2027. In February 2026 Novo Nordisk announced it would cut the US list price of Ozempic to $675 a month from the same date. Self-pay prices through NovoCare are separate; current prices are in how much Ozempic costs per month.

Outside the US, generics have arrived. A key semaglutide patent expired in India on March 20, 2026, and Indian manufacturers announced launches the same day. On April 28, 2026, Health Canada approved the first generic semaglutide, for type 2 diabetes, the first such approval in a G7 country, followed by a generic for weight loss in June 2026. In the US, generics are not expected until at least the end of 2031, and patent disputes could delay them further. Products sold online as 'generic Ozempic' in the US are not approved.

Semaglutide has more long-term data than most newer drugs: large outcome trials such as SUSTAIN-6 and FLOW followed thousands of people for years, and the drug has been used by millions since 2018. Its main known risks, including gastrointestinal effects, pancreatitis, gallbladder problems and the thyroid tumour warning based on rodent studies, are listed on the label and have not changed fundamentally since launch. Very long-term effects beyond about a decade are still being studied. The safety questions are discussed in is Ozempic safe, and recent developments in Ozempic news.

Ozempic was approved on December 5, 2017, and has been on the US market since February 5, 2018, nearly nine years. In that time it has gained heart and kidney indications and a higher dose, spawned Rybelsus, Wegovy and two pills, gone through a long shortage, and now faces lower prices in 2027 and generic competition abroad. In the US, it remains a brand-only, prescription medicine for type 2 diabetes.

This article summarizes regulatory and company announcements for general information. Dates are as reported by the cited sources.