Semaglutide Approvals by Country: Where Ozempic and Wegovy Are Approved

Semaglutide is approved in every major drug market, but what each regulator has approved, for whom, and on what date varies widely. In the United States, the Wegovy label lists initial approval in 2017 and now covers cardiovascular risk reduction, weight management in adults and children 12 and older, and noncirrhotic MASH under accelerated approval ^[12]. The European Commission authorized Ozempic on 8 February 2018 and Wegovy on 6 January 2022 ^[6][15], and added a 7.2 mg Wegovy dose and a Wegovy pill in 2026 ^[22][9].

Canada stands apart because it now has generic semaglutide. On 28 April 2026, Health Canada authorized Dr. Reddy’s generic semaglutide injection, the first generic semaglutide approved in the G7 ^[1]. That was possible because Novo Nordisk let a key Canadian patent lapse after an unpaid CAD 250 maintenance fee, while in the US the compound patent for Ozempic, Wegovy and Rybelsus runs to 2032 ^[2][3][5].

What is approved in the United States?

The current FDA Wegovy label lists 2017 as the initial US approval year for semaglutide ^[12]. The injection is approved, with diet and exercise, to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, and to reduce excess body weight long term in adults and pediatric patients aged 12 and older with obesity, and in adults with overweight plus at least one weight-related comorbidity ^[12].

The injection is also approved for noncirrhotic MASH with moderate to advanced liver fibrosis (stages F2 to F3) in adults, under accelerated approval based on improvement in MASH and fibrosis ^[12]. The label notes that continued approval may depend on verification of clinical benefit in a confirmatory trial ^[12].

Wegovy tablets come in 1.5 mg, 4 mg, 9 mg and 25 mg strengths, and the injection line includes a Wegovy HD 7.2 mg single-dose pen ^[12]. The label’s recent major changes are dated 08/2025, 12/2025 and 03/2026 ^[12]. On patents, Novo Nordisk’s Form 20-F lists US compound patent expiry for Ozempic, Rybelsus and Wegovy in 2032, and 2031 in Europe and Japan ^[3][5].

Is Ozempic approved in Europe?

Yes. The European Commission granted a marketing authorization valid throughout the EU for Ozempic on 8 February 2018, for adults with type 2 diabetes whose blood sugar is not satisfactorily controlled ^[6]. Wegovy received an EU-wide authorization on 6 January 2022 ^[15].

The EU Wegovy label covers adults with a BMI of 30 or greater, or a BMI of 27 to less than 30 with at least one weight-related health problem, and adolescents aged 12 and older whose BMI is at or above the 95th percentile for their age and gender and who weigh more than 60 kg ^[15]. The pens are for adults and adolescents 12 and older, while the tablets are for adults only ^[15]. The clinical section of the EU label also includes data on MACE risk reduction, improvements in HFpEF-related symptoms and physical function, and pain reduction related to knee osteoarthritis ^[22].

The European Commission approved a 7.2 mg once-weekly maintenance dose of Wegovy on 17 February 2026, following a CHMP opinion on 12 December 2025. In the EU, that dose is given as three 2.4 mg injections taken in one sitting ^[22]. The approval was based in part on STEP UP, a study of 1,407 participants in which people on the 7.2 mg dose lost about 21% of their body weight on average, compared with about 2% for placebo ^[22].

Is Wegovy available in the UK?

Yes, and the UK moved early on the newer options. The 7.2 mg Wegovy dose was already approved and available in the UK as of 17 February 2026, ahead of the EU decision the same day ^[22].

On 11 June 2026, the MHRA approved the semaglutide (Wegovy) tablet for weight loss and weight management, the first GLP-1 receptor agonist tablet approved in the UK for that use ^[7]. It may be prescribed to adults with a BMI of 30 or above, or a BMI between 27 and 30 with at least one weight-related comorbidity ^[7]. The UK approval came before the EU approval of the same pill on 15 July 2026 ^[7][9].

At approval, the tablet was not available on the NHS; decisions on NHS use follow established processes, including an evaluation by NICE ^[7].

The MHRA also updated semaglutide product information on 5 February 2026 regarding the very rare eye condition NAION. The agency noted three Yellow Card reports suggestive of NAION up to 1 August 2025, against an estimated 10.2 million packs of semaglutide dispensed over five years ^[11].

Which countries have the Wegovy pill?

The Wegovy pill (once-daily oral semaglutide 25 mg) has been approved in five markets: the US, the UK, the UAE, Bahrain and the EU ^[9]. The UAE launch on 3 June 2026 made it the first country outside the United States to make the pill available, following approval by the Emirates Drug Establishment ^[8].

The EU approval on 15 July 2026 followed a CHMP opinion in May 2026 ^[9]. It was based on the OASIS program, including OASIS 4, a 64-week trial in 307 adults with obesity or overweight plus at least one comorbidity, in which oral semaglutide 25 mg produced approximately 17% weight loss versus 3% for placebo ^[9].

Why does Canada have generic semaglutide?

The short answer is a lapsed patent. Novo Nordisk’s Canadian patent CA 2601784, covering acylated GLP-1 compounds, shows a last maintenance-fee payment received on 23 October 2018, and the window to reverse the lapse closed on 31 August 2020 ^[3]. The unpaid fee was CAD 250, or CAD 450 with the late fee; Novo Nordisk later called the lapse a strategic choice ^[2][3].

Canada’s certificate of supplementary protection register lists the patent expiry as 20 March 2026, with a CSP term that would have run to 20 March 2028 ^[3]. Data exclusivity expired on 4 January 2026 ^[4]. Together, that left Canada open to generic competition years ahead of other major markets.

The stakes are large. Ozempic recorded CAD 2.9 billion in Canadian sales in 2025, more than three times the next best-selling drug, and more than a million Canadians take it ^[3]. Sandoz describes Canada as the world’s second-largest semaglutide market ^[4].

What generic semaglutide products has Canada approved?

On 28 April 2026, Health Canada authorized Dr. Reddy’s Laboratories’ generic semaglutide injection, a generic version of Ozempic for once-weekly treatment of adults with type 2 diabetes, making Canada the first G7 country to approve a generic semaglutide ^[1]. Eight other submissions were under review at that point, and Health Canada completed the Dr. Reddy’s review within its 180-day target ^[1].

Apotex received approval for its Ozempic generic on 1 May 2026 ^[3]. The Dr. Reddy’s product became available in Canada on 15 May 2026, while the Apotex version did not yet have a release date as of 19 May 2026 ^[2][3]. The Dr. Reddy’s authorization covers 2 mg/pen and 4 mg/pen presentations at 1.34 mg/mL ^[3].

On 29 June 2026, reported 30 June, Health Canada approved Svemia, Apotex’s generic version of Wegovy, for chronic weight management in people aged 12 and older, alongside a reduced-calorie diet and increased physical activity ^[20]. It was the third generic semaglutide approval in Canada, and six more submissions were under review ^[20].

Health Canada notes that many generic medications in Canada are 45 to 90% cheaper than the brand-name versions, and Canadian policy is expected to drive list-price discounts of about 65% once three generic competitors are on the market ^[1][4].

Why is there no generic Ozempic in the United States?

US compound patent protection for Ozempic, Wegovy and Rybelsus runs to 2032 ^[3][5]. Several manufacturers have filed abbreviated new drug applications for generic versions of Ozempic, Wegovy and Rybelsus with Paragraph IV certifications, and Novo Nordisk has settled US Ozempic patent litigation with Alvogen, Rio Biopharmaceuticals, Sun Pharma, Dr. Reddy’s, Mylan, Zydus and Apotex, with confidential terms ^[3].

US access has instead moved through other channels, including compounding during shortages, direct-to-patient and payer programs, and Medicare drug-price negotiation ^[3]. The FDA determined in February 2025 that the semaglutide injection shortage had been resolved and then set deadlines for compounders making copies of FDA-approved semaglutide products ^[3].

As more manufacturers enter the market globally, IQVIA has warned that “the dangers of counterfeiting and substandard quality are likely to be multiplied” ^[4].

What about Australia, Japan, China and other markets?

Australia. The TGA approved Ozempic in 2019 for type 2 diabetes and Wegovy in 2022 ^[14]. Wegovy’s initial registration on the Australian Register of Therapeutic Goods was 1 September 2022 ^[13]. An adolescent indication for ages 12 and older with obesity and body weight above 60 kg was decided on 3 January 2024, with the ARTG entry dated 29 February 2024 ^[13]. In December 2024, Wegovy was approved for cardiovascular risk reduction in adults with established cardiovascular disease and a BMI of 27 or greater without diabetes, based on the SELECT study, in which major adverse cardiovascular events occurred in 6.5% of the semaglutide group versus 8.0% for placebo ^[14].

Japan. Ozempic was approved in March 2018 and Rybelsus in June 2020, both for type 2 diabetes ^[16]. Novo applied for Wegovy on 25 August 2021; a committee cleared it on 27 January 2023; and approval by the Ministry of Health, Labour and Welfare was reported in April 2023 ^[16][17]. Japan’s indication is narrower than most markets: obesity disease only, in patients with hypertension, dyslipidemia or type 2 diabetes who have not responded adequately to diet and exercise, and who have either a BMI of 27 or greater plus two obesity-related health disorders, or a BMI of 35 or greater ^[16][17]. Japanese guidelines define obesity as a BMI of 25 or greater ^[16]. On 19 June 2026, Wegovy received a partial change approval for noncirrhotic MASH with moderate to advanced fibrosis, becoming the first approved MASH treatment in Japan; in the ESSENCE study, improvement in liver fibrosis without worsening of MASH occurred in 36.8% of the semaglutide group versus 22.4% for placebo ^[18].

China. Ozempic had been on the Chinese market about three years as of June 2024, with 2023 China sales of DKK 4.82 billion ^[5]. The NMPA approved Wegovy on 25 June 2024 for people with a BMI of at least 30, or 27 to 30 with one weight-related risk factor, citing average weight loss of 17% ^[5]. China’s Supreme People’s Court upheld the semaglutide patent on 31 December 2025, and the patent expired on 20 March 2026 ^[19]. Reuters reported at least 15 GLP-1 biosimilar candidates in development in China as of June 2024 ^[5]. On 10 September 2026, Wegovy was approved in China for MASH, the first GLP-1 approved there for the liver disease ^[26][27].

India and the UAE. Wegovy launched in India in June 2025, and CDSCO approval for adolescents aged 12 and older weighing more than 60 kg was reported on 28 May 2026 ^[21]. Novo sells semaglutide under a second brand with local partners in India and Brazil, and has cut Wegovy prices in India and China ^[4]. Patents for semaglutide expire sooner in Canada, China, India and Brazil, and IQVIA estimates about one-third of the world’s adults with obesity live in markets affected by that patent cliff ^[4].

Where do regulators disagree on the NAION warning?

Labels on the eye condition NAION differ by market. EMA’s safety committee concluded on 6 June 2025 that NAION is a very rare side effect of semaglutide, meaning it may affect up to 1 in 10,000 people taking it, with large studies suggesting about a two-fold risk increase in adults with type 2 diabetes, or roughly one additional case per 10,000 person-years of treatment ^[10].

The UK updated product information on 5 February 2026 ^[11]. Australia’s TGA issued a class-wide product information update on 23 July 2026 covering GLP-1 receptor agonists, after 36 Australian cases of optic ischemic neuropathy were identified: 23 for semaglutide, 10 for tirzepatide and 3 for liraglutide. The TGA added no new prescribing restrictions ^[23][24].

A plaintiff law firm’s release states that Health Canada updated the Ozempic and Mounjaro product monographs on 23 June 2026 with enhanced NAION safety information; that date comes from the law firm’s announcement and is reported as such ^[25].

In the US, the Wegovy label’s Warnings and Precautions sections 5.1 through 5.10 do not include NAION; the suicidal behavior and ideation warning was removed in 01/2026 ^[12]. Federal GLP-1 NAION litigation is pending as a multidistrict proceeding in the US District Court for the Eastern District of Pennsylvania ^[25].

Quick reference: when was each product approved?

Market	Product	Date	Approved use
United States	Wegovy (semaglutide)	Initial approval 2017; label changes 08/2025, 12/2025, 03/2026	MACE risk reduction, weight management (adults and ages 12+), noncirrhotic MASH F2-F3 [12]
European Union	Ozempic	8 February 2018	Type 2 diabetes [6]
European Union	Wegovy injection	6 January 2022	Weight management, adults and adolescents 12+ [15]
European Union	Wegovy 7.2 mg dose	17 February 2026	Higher maintenance dose for adults with obesity [22]
European Union	Wegovy pill	15 July 2026	Weight management in adults [9]
United Kingdom	Wegovy pill	11 June 2026	Weight management in adults [7]
UAE	Wegovy pill	3 June 2026 (launch)	Weight management [8]
Australia	Wegovy injection	ARTG registration 1 September 2022	Chronic weight management [13]
Japan	Ozempic	March 2018	Type 2 diabetes [16]
Japan	Wegovy	Approval reported April 2023	Obesity disease with comorbidities [16][17]
China	Wegovy	25 June 2024	Weight management [5]
Canada	First generic semaglutide	28 April 2026	Type 2 diabetes (generic Ozempic) [1]

Sources

1. Health Canada. Canada becomes the first G7 country to approve a generic version of semaglutide. April 28, 2026.
2. The BMJ. Ozempic generic approved in Canada after Novo Nordisk doesn’t pay $250 government fee. May 19, 2026.
3. Drug Discovery and Development. Canada approves generic semaglutide from Dr. Reddy’s, a G7 first enabled by Novo Nordisk’s lapsed CAD$250 patent.
4. Benefits and Pensions Monitor. Ozempic generics set to test Canada’s drug budgets. January 16, 2026.
5. Fierce Pharma. Novo Nordisk wins approval in China for GLP-1 obesity drug Wegovy. June 25, 2024.
6. European Medicines Agency. Ozempic.
7. GOV.UK. First GLP-1 tablet for weight loss approved in the UK.
8. Novo Nordisk. Wegovy pill launches in the UAE as Novo Nordisk expands global access to obesity care. June 3, 2026.
9. Novo Nordisk. Novo Nordisk receives European Commission approval of Wegovy pill as first oral GLP-1 for weight management in the EU. July 15, 2026.
10. European Medicines Agency. PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy.
11. GOV.UK. MHRA updates guidance for semaglutide prescribers and patients.
12. US Food and Drug Administration. Wegovy (semaglutide) prescribing information. 2026.
13. Therapeutic Goods Administration. Australian public assessment report for Wegovy. September 2024.
14. Australian Prescriber. Semaglutide for cardiovascular risk reduction in people who are overweight or have obesity without diabetes (new indication).
15. European Medicines Agency. Wegovy.
16. Ministry of Health, Labour and Welfare. Report on the deliberation results: Wegovy subcutaneous injection. February 6, 2023.
17. Medthority. MHLW (Japan) approves Wegovy from Novo Nordisk to treat obesity. April 10, 2023.
18. Sumitomo Pharma. Wegovy Subcutaneous Injection, co-promoted with Novo Nordisk Pharma, approved in Japan for metabolic dysfunction-associated steatohepatitis (MASH).
19. Eagle IP. Beijing Supreme People’s Court upholds Novo Nordisk semaglutide patent in China based on post-filing data. January 23, 2026.
20. CBC News. 1st generic semaglutide injection for weight loss approved: Health Canada. June 30, 2026.
21. ETPharma. Novo Nordisk’s Wegovy approved for teens in India. May 29, 2026.
22. Novo Nordisk. The European Commission approves more effective dose of injectable Wegovy for adults with obesity. February 17, 2026.
23. RACGP. TGA issues GLP-1 RA class-wide safety update. July 23, 2026.
24. The Guardian. Australian regulator warns of ‘rare but severe’ eye disorder linked to GLP-1 drugs like Ozempic. July 24, 2026.
25. PR Newswire. Parker Waichman applauds Health Canada and Australia for strengthening NAION safety guidance for certain GLP-1 medications. July 28, 2026.
26. Dealroom.co. Novo Nordisk’s Wegovy becomes first GLP-1 drug approved in China for liver disease MASH.
27. medwatch. Novo gets China approval for Wegovy as fatty liver treatment.