Pharma Patent Cliffby readouts.io
Loss of exclusivity · Cardiometabolic

Ozempic patent expiration

When does Ozempic go off patent?

In the US, generics can launch from 2032. Ozempic is sold by Novo Nordisk. Novo guides to US compound patent expiry in 2032. Generics launched in India and Canada in 2026 as patents lapsed there. Sales DKK 127.1B.

What the date means

Ozempic's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. It is a peptide regulated as a drug rather than a biologic, so copies are generics. Peptides are harder to copy than typical pills, so generic uptake can be slower.

Patents and sales historyPatent and exclusivity dates, sales by year

Ozempic patents and exclusivity

Patent or protectionCoversExpiry
US 8,129,343Semaglutide itself and the drug product5 December 2031
US 9,132,239The drug product1 February 2032
US 10,335,462One approved use21 June 2033

Novo Nordisk guides to US compound patent expiry in 2032 for all semaglutide brands (Ozempic, Rybelsus and Wegovy). Several older formulation and pen patents listed with the FDA expire in 2026 and 2027, and Novo has asked for most of them to be removed. In October 2024 Novo settled with Mylan, Sun, Dr. Reddy's and Apotex over a challenge to a dosing patent; the terms are confidential. Generics are already sold in Canada and India, where the patents lapsed.

Sources: FDA Orange Book: Ozempic patents · Novo Nordisk 20-F 2025

Ozempic sales by year

YearWorldwideUSGrowth
2023DKK 95.7B––
2024DKK 120.3BDKK 84.2B+26%
2025DKK 127.1BDKK 88.5B+6%

Worldwide net sales as reported, with the US share, in DKK as the company reports them, so growth is not distorted by exchange rates. Source: Novo Nordisk full-year reports 2025 and 2024

Who's lined up to copy Ozempic

Tentatively approved Several makers filed generics that challenge Novo's patents. Novo has settled with seven on confidential terms, subject to review by US antitrust authorities, and guides to US compound patent expiry in 2032. Apotex won tentative approval in April 2026 and expects to launch after final approval, following that expiry.

Company (product)Stage
Mylan (Viatris)Filed with the FDA; settled, terms confidential
Sun PharmaFiled with the FDA; settled, terms confidential
Dr. Reddy'sFiled with the FDA; settled, terms confidential
ApotexTentatively approved Apr 2026; settled, terms confidential. Launch expected after final approval, following patent expiry in 2032
ZydusFiled with the FDA; settled, terms confidential
AlvogenFiled with the FDA; settled, terms confidential
Rio BiopharmaceuticalsFiled with the FDA; settled, terms confidential

Checked October 2026. Sources: Novo 20-F 2025 · Apotex: Q1 fiscal 2027 results

What past cliffs suggest

Among past small-molecule drugs facing unrestricted generics, US sales in the first full year after copies arrived were a median 18% of the last full year before (range 0% to 48%, 10 drugs), and 6% by the third year (8 drugs). Where settlements limit generic volumes, as with Revlimid, the decline is slower. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →

Medicare price negotiation

Ozempic was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 71% below its list price. That is 5 years before US generics can launch, so Medicare revenue comes under pressure first. The discount is measured against list price, before the rebates drugmakers already pay, and applies to Medicare only, so the revenue impact is smaller than the headline number. See every negotiated Medicare price →

What's at stake for Novo Nordisk

Ozempic is 41% of Novo Nordisk's 2025 revenue (≈$19.3B of $46.8B). With Wegovy, the drugs tracked here add up to 67% of Novo Nordisk's revenue losing US exclusivity by 2032. Total sales DKK 309.1B.

Bars show each company's tracked drugs as a share of its total 2025 revenue. Ozempic is highlighted.

Coming up for Ozempic

1 January 2027

Medicare negotiated prices for 2027 take effect

Discounts of 40% to 71% below list price for these drugs, before the rebates drugmakers already pay.

2032, date not disclosed

Ozempic expected to lose US exclusivity

Company guidance. Novo guides to US compound patent expiry in 2032. Generics launched in India and Canada in 2026 as patents lapsed there. Sales DKK 127.1B.

Expected LOENovo AR 2025

See every upcoming date on the patent cliff calendar →

What changed for Ozempic

  1. Outside the US
    Generic semaglutide launched in Canada

    Dr. Reddy's launched the first generic in Canada, after generics reached India in the first quarter. US protection runs to 2032. Dr. Reddy's

  2. Medicare price
    Medicare prices set for Ozempic, Pomalyst, Ibrance and Xtandi

    From 2027: Ozempic 71%, Pomalyst 60%, Ibrance 50% and Xtandi 48% below list price. CMS