Novo Nordisk

Molecules

• Semaglutide · Ozempic, Wegovy, Rybelsus
• Liraglutide · Victoza, Saxenda
• Cagrilintide (and CagriSema)
• Amycretin

Key events

1. 2026-09-18

   Health Canada approves Sandoz's generic semaglutide

   Sandoz Canada announced on 18 September 2026 that Health Canada had approved Sandoz Semaglutide, a generic version of Ozempic for adults with type 2 diabetes. It said it was preparing for commercialisation.[src]

2. 2026-07-21

   Novo Nordisk sues Eli Lilly over GLP-1 advertising

   On 21 July 2026 Novo Nordisk filed a lawsuit against Eli Lilly in federal court in New Jersey, according to CNBC. Novo alleges false advertising and unfair competition, including under the Lanham Act, in Lilly's advertising for its obesity and diabetes medicines such as Zepbound. Lilly said it stands firmly behind its advertising. These are allegations that no court had ruled on at the time of the report.[src]

3. 2026-07-01

   Medicare GLP-1 Bridge set to start, with a $50 co-pay for eligible weight-management prescriptions

   CMS's Medicare GLP-1 Bridge, a short-term demonstration, was set to give eligible Part D beneficiaries access to certain GLP-1 drugs for weight management at a $50 co-pay from 1 July 2026, outside the normal Part D benefit. CMS lists Wegovy (injection and tablets), Foundayo and Zepbound (KwikPen) as eligible. In April 2026 CMS extended the Bridge to run through 31 December 2027.[src]

4. 2026-06-11

   UK MHRA approves the first GLP-1 tablet for weight loss

   On 11 June 2026 the MHRA approved semaglutide (Wegovy) tablets in the UK for weight loss and weight management in adults who meet BMI criteria. The MHRA noted that, as with all GLP-1 receptor agonists, it is a prescription-only medicine.[src]

5. 2026-04-28

   Health Canada approves the first generic semaglutide, a generic Ozempic from Dr. Reddy's

   Health Canada announced on 28 April 2026 that Canada had become the first G7 country to approve a generic semaglutide, approving Dr. Reddy's generic version of Ozempic for adults with type 2 diabetes.[src]

6. 2026-03-21

   Generic semaglutide launches in India after Novo Nordisk's core patent expires

   On 21 March 2026 several Indian drugmakers, including Dr Reddy's, Zydus, Alkem, Sun Pharma and Glenmark, launched generic semaglutide products, described as day-one entry on expiry of Novo Nordisk's core Indian semaglutide patent.[src]

7. 2026-03-09

   Novo Nordisk drops its patent lawsuit against Hims & Hers and the two companies agree a deal

   On 9 March 2026 Novo Nordisk said it was dropping a lawsuit that claimed Hims & Hers infringed a Wegovy patent, and reserved the right to refile. Hims & Hers agreed to stop advertising compounded GLP-1 products and to offer branded Wegovy, but said it may still provide compounded versions when a provider judges them clinically necessary, according to STAT News.[src]

8. 2026-02-05

   TrumpRx.gov launches with GLP-1 cash prices from Lilly and Novo Nordisk

   The White House launched TrumpRx.gov on 5 February 2026. Its fact sheet said Ozempic and injectable Wegovy would cost an average of $350 and as low as $199 per month, the Wegovy pill as low as $149, and Zepbound an average of $346 and as low as $299. These are government-stated prices for cash purchases.[src]

9. 2025-12-22

   FDA approves the Wegovy pill (oral semaglutide) for weight loss

   Novo Nordisk announced on 22 December 2025 that the FDA had approved Wegovy tablets for weight management in adults with obesity or overweight and a related condition, and for reducing cardiovascular risk in people with established cardiovascular disease. In the OASIS 4 trial, the company said people who stayed on treatment lost about 17% of body weight versus about 3% on placebo, or about 14% versus about 2% when everyone was counted regardless of whether they stayed on treatment.[src][src]

10. 2025-12-19

    Australia's PBAC publishes advice on subsidising GLP-1 obesity treatments

    The Pharmaceutical Benefits Advisory Committee published its November 2025 outcome on 19 December 2025. It advised a slow, managed roll-out to priority groups such as people with established cardiovascular disease, and separately recommended listing Wegovy on the PBS for people with established cardiovascular disease and obesity.[src]

11. 2025-11-07

    Metsera accepts Pfizer's offer after a bidding contest with Novo Nordisk

    According to BioPharma Dive, Metsera's board accepted Pfizer's offer of up to $86.25 per share (more than $10 billion including contingent payments) on 7 November 2025. The deal ended a contest with Novo Nordisk that had involved lawsuits.[src]

12. 2025-11-06

    White House announces pricing agreements with Eli Lilly and Novo Nordisk

    On 6 November 2025 the White House announced agreements with Lilly and Novo Nordisk that it said would set Medicare and Medicaid prices for Ozempic, Wegovy, Mounjaro and Zepbound at $245, with a $50 monthly co-pay for Medicare patients covered for obesity. It also described lower cash prices through TrumpRx, and US manufacturing investment pledges from both companies.[src]

13. 2025-11

    CMS publishes a Medicare negotiated price for semaglutide, effective 2027

    In November 2025 CMS published negotiated Medicare prices for the 2027 price applicability year. For Ozempic, Rybelsus and Wegovy it lists a negotiated price of $274 for a 30-day supply, against a 2024 list price of $959, a 71% discount. The prices apply from 2027.[src][src]

14. 2025-08-28

    FDA approves and Teva launches the first generic GLP-1 for weight loss in the US

    Teva announced on 28 August 2025 that the FDA had approved, and it had launched, a generic version of Saxenda (liraglutide). Teva described it as the first generic GLP-1 medicine indicated for weight loss.[src]

15. 2025-08-05

    Novo Nordisk announces 14 more lawsuits over compounded 'semaglutide'

    On 5 August 2025 Novo Nordisk said it had filed 14 new lawsuits over compounded products marketed as semaglutide, extending its cases to certain compounding pharmacies and telehealth companies. It said it had by then filed 132 complaints in federal courts across 40 states, and that courts had issued 44 permanent injunctions in similar cases. The company's statements are its own account of the litigation, and the new complaints are allegations.[src]

16. 2025-07-01

    CVS Caremark stops covering Zepbound and keeps Wegovy

    From 1 July 2025, CVS Caremark, a large US pharmacy benefit manager, stopped covering Zepbound for its members and continued to cover Wegovy. CVS said the decision was intended to make the two manufacturers compete on price.[src]

17. 2025-06-22

    REDEFINE 1: CagriSema leads to about 20% weight loss at 68 weeks

    In the REDEFINE 1 phase 3 trial of 3,417 adults with obesity or overweight, the cagrilintide-semaglutide combination (CagriSema) produced an estimated mean weight change of -20.4% at week 68, versus -3.0% with placebo. CagriSema was an investigational combination when these results were published.[src]

18. 2025-05-11

    SURMOUNT-5: tirzepatide beats semaglutide for weight loss in a head-to-head trial

    In a 72-week randomised trial of 751 adults with obesity, average weight loss was 20.2% with tirzepatide and 13.7% with semaglutide. Results were published in NEJM.[src]

19. 2025-04-24

    Court denies compounders' request to block the semaglutide shortage decision

    On 24 April 2025 the federal district court in the Northern District of Texas denied the preliminary injunction sought by the Outsourcing Facilities Association in its case over the FDA's semaglutide decision. The court had denied a similar request about tirzepatide on 5 March 2025, so the FDA's enforcement grace periods proceeded.[src]

20. 2025-02-21

    FDA declares the semaglutide shortage resolved

    On 21 February 2025 the FDA determined that the shortage of semaglutide injection products was resolved. Its enforcement grace periods for compounders ended on 22 April 2025 for state-licensed pharmacies and 22 May 2025 for outsourcing facilities, or later depending on a pending court decision.[src][src]

21. 2024-03-08

    FDA adds a heart-protection indication to Wegovy

    On 8 March 2024 the FDA approved a new indication for Wegovy: reducing the risk of cardiovascular death, heart attack and stroke in adults with established cardiovascular disease and either obesity or overweight. The approval followed the SELECT trial.[src]

22. 2023-11-11

    SELECT trial: semaglutide lowers heart-attack and stroke risk in people with obesity and heart disease

    In the SELECT trial of 17,604 adults with overweight or obesity and existing cardiovascular disease but no diabetes, a major cardiovascular event occurred in 6.5% of the semaglutide group and 8.0% of the placebo group (hazard ratio 0.80) over an average of about 40 months.[src]

23. 2022-03

    FDA lists Wegovy, then Ozempic, as in shortage

    According to a law-firm summary of the FDA's actions, the FDA added Wegovy to its drug shortage list in March 2022 and Ozempic in August 2022. While an approved drug is listed as in shortage, US compounders may make copies of it under conditions that otherwise do not apply.[src][src]

24. 2022-01-06

    European Commission authorises Wegovy for weight management

    The EU marketing authorisation for Wegovy was issued on 6 January 2022, after the EMA's human medicines committee adopted a positive opinion on 11 November 2021. It covers weight management in adults with obesity, or with overweight and at least one weight-related condition.[src]

25. 2021-06-04

    FDA approves Wegovy (semaglutide) for chronic weight management

    The FDA approved Wegovy, a weekly injected form of semaglutide, on 4 June 2021 for chronic weight management in adults with obesity or with overweight plus a weight-related condition.[src]

26. 2021-02-10

    STEP 1 trial: weekly semaglutide leads to about 15% weight loss over 68 weeks

    The STEP 1 phase 3 trial, published in NEJM, enrolled adults with overweight or obesity without diabetes. Average body weight fell 14.9% at week 68 with semaglutide versus 2.4% with placebo, alongside lifestyle support.[src]

27. 2019-09-20

    FDA approves Rybelsus, a tablet form of semaglutide, for type 2 diabetes

    The FDA approved Rybelsus (semaglutide tablets) on 20 September 2019 for adults with type 2 diabetes. It is a tablet version of semaglutide taken by mouth rather than by injection.[src][src]

28. 2017-12-05

    FDA approves Ozempic (semaglutide) for type 2 diabetes

    The FDA approved Ozempic, a once-weekly injected form of semaglutide, on 5 December 2017 for adults with type 2 diabetes. Semaglutide is the active ingredient later sold as Wegovy for weight management.[src]

29. 2014-12-23

    FDA approves Saxenda (liraglutide) for chronic weight management

    The FDA approved Saxenda, a daily injected form of liraglutide, on 23 December 2014 for long-term weight management in adults with obesity or with overweight plus a weight-related condition. It was a GLP-1 medicine approved for weight loss before semaglutide and tirzepatide.[src][src]

30. 2010-01-25

    FDA approves Victoza (liraglutide) for type 2 diabetes

    The FDA approved Victoza, a once-daily injected form of liraglutide, on 25 January 2010. Liraglutide is also the active ingredient of Saxenda, which is approved for weight management.[src][src]