Semaglutide loses exclusivity in eight countries in first wave of 2026 patent expiries

Semaglutide, the active ingredient in Ozempic and Wegovy, has begun losing patent and data protection in eight countries — the first wave of expiries opening the drug to off-patent competition ^[1]. Canada, Brazil, China, India, Mexico, Turkey, Saudi Arabia and South Africa make up that first wave, according to IQVIA, a health data and consulting firm ^[1]. Both the diabetes and obesity uses of the drug lose protection in those markets ^[1].

The eight markets are not a small slice. Together they account for 38 percent of the world's adults living with obesity, IQVIA estimates ^[1]. In a July 2025 analysis, IQVIA said India, Canada, China, Brazil and Turkey alone make up about 40 percent of the world's population and roughly 33 percent of the world's adults living with obesity ^[2]. Semaglutide remains under patent in many other countries until the early 2030s ^[2].

How the drug is regulated varies widely by market. Canada and Saudi Arabia treat semaglutide as a chemical drug and require only bioequivalence studies, IQVIA says. Brazil, India and South Africa classify it as a biologic, with India requiring local Phase III-style clinical trials. China is mixed: a biologic if recombinant, a chemical drug if synthetic, but with full clinical studies required either way. Turkey generally follows European Medicines Agency practice ^[1]. Saudi Arabia's local patent was never filed, so the country never had a standard market protection period ^[1].

Competition is building in those markets. IQVIA has identified more than 70 integrated pharmaceutical companies applying for marketing authorization and another 70 companies able to manufacture semaglutide's active ingredient for others. China has the highest concentration of semaglutide manufacturing, with India second ^[1]. In China, 17 candidates have reached Phase III trials or the pre-market application stage, 9 of them running trials in obesity ^[2]. In India, more than 10 companies filed submissions with the Subject Expert Committee to run Phase III studies, 7 of them for oral semaglutide ^[2]. Most companies are developing both oral and vial versions to avoid relying on injection pens ^[1].

Prices have already moved in India, where IQVIA reports multi-dose vials at $14 a month and disposable pens at $19 a month for the lowest dose forms, a discount of up to 90 percent ^[1]. A study led by Professor Andrew Hill estimated finished semaglutide pens could sell to patients for $2.50 to $12 a month, but IQVIA says that figure underestimates costs such as sourcing across geographies and the market-access process, and that it assumes a cost-plus model most companies do not use ^[1]. IQVIA describes the pricing question as "one with many opinions and little hard fact at present" ^[1].

Why it matters for patients

The United States is not in this first wave. IQVIA places the US in the third and largest wave of markets to lose exclusivity, after a second wave starting with the Baltics and parts of Central and Eastern Europe ^[1]. No US supply or pricing change follows directly from these eight expiries.

For patients in the eight countries, the practical effect depends on how each regulator classifies the drug. Where semaglutide is handled as a generic, pharmacists may be able to substitute prescriptions on price; where it is handled as a biosimilar, the choice typically stays with the prescriber ^[2]. Public reimbursement remains limited in most of these markets, so IQVIA expects the first competition to play out in the private, out-of-pocket market ^[1]. In Canada, generic pricing rules could require discounts of up to 75 percent against the originator product, which IQVIA suggests could open the door to broader public and private coverage ^[2]. How far and how fast prices fall across these countries has not been established ^[1].

What happens next

Entry into these markets is expected to be staggered because of regulatory complexity, the volume of submissions and manufacturing problems ^[1]. IQVIA expects obesity prevalence in the eight countries to keep rising through 2050 — Mexico up 18 percent, Brazil up 17 percent and Saudi Arabia up 16 percent — which it cites as evidence of unmet demand ^[1]. Specific timing for the second wave beyond the Baltics and parts of Central and Eastern Europe, and for the third wave covering the US and most of Europe, has not been reported ^[1].