Last updated: 24 September 2026. We review this page monthly as approvals and court rulings change the picture.
Semaglutide's core patent expired on 20 March 2026 in most of the world, but "expired" doesn't mean "open". As of September 2026, generic semaglutide is on sale in India, Canada, Brazil, South Africa and Saudi Arabia. China and Mexico are still closed by data protection despite the patent expiring, and the US, the EU, the UK and Japan stay protected until around 2031–2032. This guide sets out the status market by market, the patents people forget, and what it means if you're buying or making semaglutide.
Why 20 March 2026 mattered
Novo Nordisk filed the core semaglutide patent family on 20 March 2006. A patent lasts 20 years from filing, so wherever Novo had no extension, protection ended on 20 March 2026. Where regulators granted an extension to make up for the years lost in development and approval, as in the US, Europe and Japan, it runs for several more years.
That single date split the world into three groups. It's worth being precise about which group a market sits in. There's been a lot of loose talk since March about semaglutide being "off patent". In several of the world's biggest markets, it isn't.
Semaglutide patent status by country: the short answer
| Market | Core patent | Generics on sale? | What still blocks or limits |
|---|---|---|---|
| India | Expired 20 Mar 2026 | Yes, injectables from 21 Mar 2026, dozens of brands | Oral tablets: formulation patent to 2031 |
| Canada | Lapsed in 2019 (fee not paid); data protection ended 4 Jan 2026 | Yes, since mid-May 2026 | Pen device patents reported to run to at least 2033 |
| Brazil | Expired 20 Mar 2026; extension refused | Yes, first approval May 2026 | Approvals so far are diabetes pens |
| South Africa | Expired Mar 2026 | Yes, first launch Aug 2026 | 13 more applications pending |
| Saudi Arabia | No local patent reported | Yes, first launch 16 Sep 2026 | Other GCC states need their own approvals |
| China | Expired 20 Mar 2026 | Not yet | Data protection to about April 2027 |
| Mexico | Expired Mar 2026 | Not yet | Court-granted data protection, about 2029 (being contested) |
| Russia | Not confirmed | Local production under compulsory licences | Licences are time-limited |
| United States | Extended to 5 Dec 2031 | No | Settlements point to entry around 2032; many secondary patents |
| EU and UK | SPCs to about March 2031 | No | Enforced against compounded copies |
| Japan | Extended to about 2031 | No | Oral generics already being lined up |
Status as of 24 September 2026. Patent positions change with court rulings, so treat this as a map, not a legal opinion.
India: the price war started on day one
India's core patent expired on 20 March 2026, and generic launches followed the next morning. Among the first were Dr Reddy's (Obeda), Sun Pharma (Noveltreat and Sematrinity), Zydus (Semaglyn and others, co-marketed by Lupin), Alkem, Glenmark, Natco, Mankind and Torrent.
The prices tell the story. Before expiry, Ozempic cost about ₹8,800–11,175 a month and Wegovy up to ₹16,400. The generics launched at roughly ₹1,800–4,200 a month for pens, with Glenmark at ₹325–440 a week and Natco's vials from ₹1,290 a month. Ten days later, Novo cut Ozempic by 36% and Wegovy by 48%. That's what a real generic market looks like: not a gentle discount but a reset.
Two details matter for anyone doing business out of India:
- Tablets are still protected. A formulation patent covering semaglutide tablets with the absorption enhancer SNAC in a set range runs to 2031. Dr Reddy's and Torrent gave the Delhi High Court undertakings that their tablets fall outside that range, and the court told Sun to seek permission before launching tablets. I couldn't confirm any generic tablet actually on sale.
- Export was cleared early. Before expiry, the Delhi High Court allowed Dr Reddy's, and later Sun, to make semaglutide for export to countries where Novo holds no patent. That's why Indian product could reach markets like Canada so quickly.
Novo also sued Dr Reddy's over the brand name "Olymviq", arguing it was too close to Ozempic. It didn't get an injunction, but it's a reminder that trademarks are a second front once patents fall.
Canada: the G7 test case
Canada is the story every IP lawyer now tells. Novo's Canadian patent lapsed in 2019 because a maintenance fee wasn't paid. What kept generics out until 2026 was data protection, which ended on 4 January 2026.
Health Canada approved the first generic, from Dr Reddy's, on 28 April 2026, and Apotex followed on 1 May. Both reached pharmacies in mid-May, with Apotex reported at about a third of Ozempic's price. Apotex's Sevmia became the first generic approved for weight loss on 29 June, and Sandoz was approved on 18 September. Canada's pricing rules push generics down to 35% of the brand price once three are on the market.
Novo's own reading is useful: in its half-year report it said Canada brought lower realised prices while volumes stayed broadly stable. In plain terms, the market didn't shrink, the money in it did.
Brazil, South Africa and Saudi Arabia: the next wave
Brazil. The patent expired on 20 March 2026 after Brazil's Superior Court of Justice unanimously refused Novo an extension. ANVISA approved the first generic pen, EMS's Ozivy, in May, followed in July and August by products from Hypera, Sun, Ranbaxy, Cosmed, Ávita, Germed and EMS again. Ozivy sells at about R$452–498 a pen against R$975–999 for Ozempic. All approvals so far are for type 2 diabetes.
South Africa. Sun, through Ranbaxy, launched Semagard in August 2026, about 18.5% below Ozempic, with 13 more applications pending. Novo answered with a cheaper Ozempic variant. The early discount is modest, which tells you the real price fall is still to come as more approvals land.
Saudi Arabia. No local patent was reportedly ever filed. Hikma launched Glucentra, made by OneSource, on 16 September 2026, the first generic semaglutide in the Kingdom. Other Gulf states need their own approvals, and I found nothing confirmed yet.
China and Mexico: patent expired, market still closed
These two are the most important lesson in this article: a patent is not the only wall.
China. The patent was challenged and briefly invalidated, but China's Supreme People's Court upheld it in December 2025, and it expired on schedule on 20 March 2026. Yet no generic has been approved, because data protection under the China–Switzerland free trade agreement runs to about April 2027. Huadong, Jiuyuan, Livzon, CSPC, United Labs, Qilu and others have filed and are waiting. When China opens, expect it to open fast and at very low prices.
Mexico. The patent expired in March, but a Mexican court granted data protection for ten years from the product's registration in July 2019. On that reading it runs to about July 2029. The generic industry association is contesting it. As of late August, COFEPRIS hadn't approved a generic.
United States, Europe and Japan: 2031 and beyond
United States. The main compound patent runs to 5 December 2031 with its term extension. Novo settled with several generic filers, including Mylan (Viatris), on confidential terms, and analysts expect entry around 2032. Apotex, with Orbicular, received the first FDA tentative approval for a generic Ozempic in April 2026, which means approved but not yet allowed to launch. Novo sued Cipla over its filing in 2026.
Prices are falling anyway, through policy rather than competition. Medicare's negotiated price for semaglutide is $274 for a 30-day supply from 2027, against a $959 list price. Novo has announced that the US list price of Wegovy, Ozempic and Rybelsus will drop to $675 a month from 1 January 2027. Meanwhile, the FDA ended the shortage that allowed mass compounding in February 2025 and has been tightening enforcement against compounded GLP-1s since.
European Union and UK. Supplementary protection certificates extend protection to about March 2031. A Dutch court showed in August 2026 that Novo will enforce them: it ordered a hospital pharmacy to stop supplying its own compounded semaglutide. Sandoz filed a challenge at the Unified Patent Court in June 2026 against a dosing patent covering 18 countries. IQVIA has suggested some Central and Eastern European markets may open earlier, but I couldn't confirm which, so don't plan on it without a country-level check.
Japan. Protection is extended to about 2031. South Korea's Samchundang has already partnered with Daiichi Sankyo Espha to sell oral semaglutide generics in Japan when the time comes.
The patents people forget
When people say "the semaglutide patent", they mean the compound. But Novo's protection is layered, and the layers expire at different times:
- Oral tablets (Rybelsus and the Wegovy pill). The SNAC absorption technology is protected separately, to 2031 in India and into the 2030s in the US. An injectable generic doesn't give you a tablet generic.
- Pen devices. In Canada, pen patents are reported to run to at least 2033. A generic may need its own device or a device outside the patent.
- Doses and uses. Patents on specific doses or indications, such as cardiovascular risk reduction, can outlast the compound patent in some markets. That's one reason most generics approved outside India and Canada are for type 2 diabetes only, not weight management.
- Trademarks. As the "Olymviq" case in India showed, a brand name that sounds too close to Ozempic invites a lawsuit.
What this means if you're buying semaglutide
Whether you can legally buy and sell generic semaglutide depends on where it's going, not where it's made. A pen legally made in India can be sold in Canada or Brazil today, but not in Germany until about 2031. Before you issue a purchase order, settle these points:
- Is the product registered in your market? If not, the only legal route is usually Named Patient Import for a specific patient, not commercial supply.
- Which indication is approved? Many generics are approved for type 2 diabetes only. Selling them for weight management may be off-label in your market.
- How is it made? Semaglutide can be made by chemical synthesis or by recombinant (biological) methods. Regulators such as the EMA may treat the first as a generic and the second as a biosimilar, with different evidence requirements. Ask for the impurity profile and the regulatory basis for approval.
- Is it the tablet or the injection? Tablets remain patent-protected in more places for longer.
- Can your cold chain handle it? Pens need 2–8°C storage until first use.
And one warning. Semaglutide offered cheaply, in quantity, without a registration in your market is a red flag, however good the paperwork looks. Since 2025 regulators from the US to the Netherlands have acted against unauthorised copies. If a price looks too good to be legal, it probably is.
We list semaglutide on PharmaTradz as Ozempic-strength pens and Wegovy strengths. Any enquiry is matched against where the product can legally be supplied.
What this means if you're manufacturing it
- The open markets are crowding fast. India's prices fell by half or more on day one, and Canada's pricing rules push generics to 35% of the brand price. Being first in a market now matters more than being cheapest.
- The next windows are known. China is expected around 2027, Mexico possibly 2029 depending on the court challenge, and the US, EU, UK and Japan around 2031–2032. A registration filed now for 2031 isn't early.
- Export rights need checking market by market. Indian manufacturers won court clarity to export to countries without a Novo patent, but every destination still needs its own freedom-to-operate check against the secondary patents above.
- Novo is fighting on price as well as in court. It cut prices in India by up to 48%, launched savings cards in Canada and a cheaper variant in South Africa. Its 2026 guidance, first −5% to −13% sales growth and later revised to 0% to −6%, shows how seriously it takes the threat and how much it has managed to hold.
Frequently asked questions
When did the semaglutide patent expire?
The core patent expired on 20 March 2026 in markets without an extension, including India, China, Brazil and South Africa. In Canada it lapsed in 2019. In the US it runs to 5 December 2031, and in the EU, UK and Japan to about 2031.
Where is generic semaglutide available?
As of September 2026, generic semaglutide injections are on sale in India, Canada, Brazil, South Africa and Saudi Arabia. Russia has local production under compulsory licences.
Why isn't generic semaglutide available in China yet?
The patent expired in March 2026, but data protection under the China–Switzerland free trade agreement runs to about April 2027. Several Chinese manufacturers have filed and are waiting for approval.
Is generic Rybelsus (oral semaglutide) available?
Not that we could confirm. The tablet formulation is protected by separate patents, to 2031 in India and into the 2030s in the US.
When will generic Ozempic be available in the US?
Not before the compound patent expires on 5 December 2031. Settlements with generic companies point to entry around 2032, although one generic has already received FDA tentative approval.
If you need semaglutide for a market where generics can legally be supplied, send us an RFQ with the destination country, strength and quantity, and we'll tell you which registered sources can supply it. If you manufacture semaglutide and want buyers in the open markets, list your product with us.
This article is for information only and is not legal advice. Patent and exclusivity positions change with court decisions and regulatory approvals. Anyone planning to manufacture, import or sell semaglutide should get a freedom-to-operate opinion for each market.
Sources
- Inside Novo Nordisk's semaglutide litigation blitz (SpicyIP, March 2026)
- Generic semaglutide launches in India (Pearce IP, March 2026)
- Dr Reddy's, Sun Pharma, Glenmark kick off generic semaglutide price war (ThePrint, March 2026)
- Indian drugmakers set to launch generics (Fierce Pharma, March 2026)
- First movers as India's semaglutide market opens (Business Today, March 2026)
- Delhi High Court denies injunction (ip fray, March 2026)
- Novo Nordisk cuts Ozempic, Wegovy prices in India (Business Standard, March 2026)
- Dr Reddy's undertaking on oral semaglutide patent (Supreme Today, March 2026)
- Delhi HC directs Sun Pharma to seek permission before launching tablets (August 2026)
- HC clears Dr Reddy's semaglutide exports (Business Standard, December 2025)
- The semaglutide story in Canada (Mondaq, August 2025)
- Canada approves second generic semaglutide (Health Canada, May 2026)
- Canada approves first generic semaglutide for weight loss (Health Canada, June 2026)
- Sandoz's generic semaglutide approved in Canada (Pearce IP, September 2026)
- Generic semaglutide sales begin in Canada (Global News, May 2026)
- Novo Nordisk responds to generics in Canada (Global News, May 2026)
- Off-patent semaglutide in 2026 (IQVIA, April 2026)
- STJ refuses semaglutide patent adjustment (JOTA, December 2025, Portuguese)
- Brazil approves first generic semaglutide pen (Reuters, May 2026)
- ANVISA approvals and prices (O Tempo, September 2026, Portuguese)
- South Africa's semaglutide market opens to generic competition (Generics Bulletin, July 2026)
- First generic hits South Africa (Bhekisisa, August 2026)
- Hikma launches Glucentra in Saudi Arabia (Hikma, September 2026)
- China's Supreme People's Court upholds semaglutide patent (Eagle IP, January 2026)
- Novo sees generic Ozempic delayed in China until next year (Bloomberg via Swissinfo, May 2026)
- Chinese semaglutide filers (TMTPost, April 2026)
- ANAFAM contests extended protection in Mexico (La Jornada, July 2026, Spanish)
- Russian compulsory licences for semaglutide (GxP News, January 2026)
- Overpatented, overpriced (I-MAK, June 2025)
- The patent landscape for Ozempic, Wegovy and Rybelsus (Markman Advisors, February 2025)
- Novo's settlement with Mylan (Fierce Pharma, October 2024)
- Apotex receives first FDA tentative approval for generic Ozempic (Apotex, April 2026)
- Novo Nordisk half-year report 2026 (August 2026)
- Medicare negotiated prices for 2027 (BioPharma Dive, November 2025)
- Novo Nordisk announces US list price reduction (Novo Nordisk, February 2026)
- FDA clarifies policies for compounders (US FDA)
- Dutch court blocks compounded semaglutide (Tech Times, August 2026)
- Ozempic patent expiry (Abel + Imray, April 2026)
- Korean oral semaglutide generics for Japan (BusinessKorea, January 2026)
- Novo Nordisk 2026 outlook (BioPharma Dive, February 2026)
