Key Highlights
- Semaglutide is a GLP-1 receptor agonist used for type 2 diabetes and obesity treatment, sold under Ozempic®, Wegovy®, and Rybelsus®.
- Available in injectable (weekly) and oral (daily)
- Novo Nordisk’s sales surged in Q1 2025, with obesity care driving 65% growth.
- Next-gen product CagriSema (semaglutide + cagrilintide) is in development; regulatory filing expected in early 2026.
- U.S. and EU markets are protected until 2031 due to core patents and SPCs—no generic entry expected before then.
- Generic entry expected in most other markets starting 2026:
- Canada: The patent has lapsed; generics may launch as early as January 2026, following the expiry of data protection exclusivity
- India, China, Brazil: Key patents expire March 2026; litigation unlikely to delay launch.
- Generic players like Reddy’s, Biocon, Sun Pharma, Cipla, Lupin, Sun Pharma, Aurobindo Pharma Cipla, Zydus, Hypera and Sandoz are scaling up manufacturing and regulatory filings for 2026 launches.
Introduction
Semaglutide is a prescription medication primarily used to treat type 2 diabetes and for long-term weight management in people with obesity or overweight conditions. It belongs to the class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists, which mimic the natural hormone GLP-1 involved in blood sugar regulation and appetite control.
Semaglutide works by:
- Increasing insulin secretion from the pancreas when blood sugar is high.
- Reducing the release of glucagon, a hormone that raises blood sugar.
- Slowing gastric emptying, which delays how quickly food leaves the stomach.
- Decreasing appetite, leading to reduced food intake and weight loss.
It is available in two main forms:
- Subcutaneous injection(once weekly), sold as brands Ozempic (primarily for diabetes) and Wegovy (for weight loss).
- Oral tablet(daily), sold as Rybelsus for diabetes management
Leading Innovators in GLP-1 Drug Development
- Novo Nordisk: Pioneered liraglutide and semaglutide-based products (Victoza, Saxenda, Ozempic, Rybelsus, Wegovy).
- Eli Lilly: Developed dulaglutide (Trulicity) and tirzepatide (Mounjaro, Zepbound).
- AstraZeneca: Innovator of exenatide (Byetta, Bydureon).
- Sanofi: Developed lixisenatide (Lyxumia, Adlyxin), as well as combination products.
- GSK: Developed (and later discontinued) albiglutide (Tanzeum).
- Hanmi Science: Pipeline innovator (efpeglenatide, efinopegdutide)
Market Performance
Novo Nordisk, the innovator of semaglutide, has been selling and expanding its semaglutide-based products, primarily for diabetes and obesity care, with strong sales growth reported recently. As of the first quarter of 2025, Novo Nordisk’s total sales reached DKK 78.1 billion (about $11.9 billion), representing an 18% increase at constant exchange rates compared to the same period in 2024. Within this, sales in the Diabetes and Obesity care segment accounted for DKK 73.5 billion, driven by a 65% growth in obesity care sales (mainly their semaglutide product Wegovy) and 11% growth in GLP-1 diabetes sales (including Ozempic, another semaglutide product)
Pipeline Developments: CagriSema
Building on semaglutide’s clinical success, Novo Nordisk is advancing CagriSema, a next-generation, fixed-dose combination of semaglutide and cagrilintide. Early clinical data shows promising results in both weight management and glycemic control. Regulatory submissions are expected in early 2026.
Proposed Market Entry Timeline for Semaglutide Generics
Semaglutide’s global patent landscape indicates that generic entry is unlikely in the U.S. and Europe before 2031, due to key protections. In the United States, a core Orange Book-listed patent with a Patent Term Adjustment extends exclusivity to December 5, 2031. In Europe, although several formulation patents have been revoked, the compound patent is supported by a Supplementary Protection Certificate (SPC) valid until March 19, 2031.
However, in most other major markets—including India, China, Brazil, and Canada—compound patents expire in early 2026, opening the door for generic competition. Canada’s patent has already lapsed, enabling potential launches as early as January 2026, while active litigation in India and China is unlikely to delay generic entry beyond March 2026. As a result, widespread global competition for semaglutide is expected to begin in 2026, with the notable exception of the U.S. and EU, where exclusivity may hold until 2031.
United States – Semaglutide Protection Status
The international application WO2006/097537 (PCT filed on 20 March 2006) forms the basis for key U.S. patents covering semaglutide.
- U.S. Patent No. 8,536,122 (US8536122B2) is anticipated to expire on 20 March 2026.
- U.S. Patent No. 8,129,343 (US8129343), which includes a Patent Term Adjustment (PTA) of 1,046 days, is listed in the FDA Orange Book with an expiry date of 5 December 2031.
These patents provide core protection for semaglutide-based products, including Ozempic®, Rybelsus®, and Wegovy®, in the U.S. market.
Europe – Semaglutide Protection Status
The regulatory data protection for semaglutide expires on 4 January 2026. The underlying compound patent, which provides coverage for semaglutide and supports marketed products such as Ozempic®, Rybelsus®, and Wegovy®, is scheduled to expire on 20 March 2026.
An SPC (Supplementary Protection Certificate) has been granted for semaglutide or a pharmaceutically acceptable salt thereof, extending the effective period of protection until 19 March 2031, representing the maximum allowable SPC term under EU regulations.
EPO Revokes Key Novo Nordisk Patents on Oral Semaglutide Delivery
11 October 2024 – The European Patent Office (EPO) Boards of Appeal revoked two key Novo Nordisk patents related to oral semaglutide delivery. Patent EP2827845, covering a delivery agent composition for the tablet form (Rybelsus®), was invalidated after Novo Nordisk withdrew its appeal (T2044/21-3.3.0), following earlier opposition from Teva, Galenicum, Generics Ltd, Hexal, and others.
Similarly, EP2827885, which related to GLP-1 peptide compositions, was revoked after opposition (T0291/22-3.3.04), with the EPO upholding the prior refusal.
16 May 2025 – The EPO also revoked EP2866825, another semaglutide-related patent underpinning Ozempic® and Wegovy®, following challenges by Teva, Generics UK, and Galenicum.
Oppositions are ongoing against other semaglutide use patents, including EP3448416 for cardiovascular indications, which has been upheld in amended form but is currently under appeal.
China – Semaglutide Protection Status
The primary product patent protecting semaglutide in China, CN101133082B, is scheduled to expire on 20 March 2026.
In September 2022, the validity of this patent was challenged. The Patent Reexamination and Invalidation Department (PRID) initially invalidated the patent, citing China’s strict limitations on post-filing data. Although Novo Nordisk submitted post-filing experimental evidence to demonstrate the improved efficacy of semaglutide over liraglutide, the PRID held that such data could not establish the claimed technical effect, as the evidence was not included in the original disclosure and thus could not be “undoubtedly obtained” from the original application.
Novo Nordisk subsequently appealed the decision. The Beijing Intellectual Property Court overturned the invalidation and accepted the post-filing data, thereby maintaining the validity of CN101133082B. However, Huadong has appealed this ruling to the Supreme People’s Court (Intellectual Property Tribunal). Given the typical timelines involved, a final decision is unlikely before the patent’s scheduled expiry in March 2026.
India – Semaglutide Protection Status
Patent Status: Indian product patent IN262697B (Application No. IN5107/DELNP/2007) for semaglutide expires in March 2026.
Ongoing Patent Dispute
Parties Involved:
- Plaintiff: Novo Nordisk (developer of Ozempic, Wegovy, Rybelsus)
- Defendants:
- Dr. Reddy’s Laboratories – obtained CDSCO licences for semaglutide
- OneSource Specialty Pharma Ltd. – contract manufacturer for Dr. Reddy’s
Allegations:
Novo Nordisk filed a patent infringement suit in the Delhi High Court, alleging that the defendants imported semaglutide API and manufactured formulations without authorization, infringing Patent No. 262697.
Novo’s Position:
Asserts infringement under Section 48 of the Patents Act, arguing that large-scale manufacture—even for export—violates its exclusive rights.
Dr. Reddy’s Defence:
Invokes Section 107A(b) (Bolar exemption), claiming exports are for regulatory and commercial purposes in jurisdictions without active Novo patents, and hence, non-infringing.
Interim Ruling – May 29, 2025:
- Injunction granted: Defendants barred from selling semaglutide within India (no marketing licence).
- Export allowed: Court declined to restrain manufacturing/export, noting further adjudication is needed to decide applicability of Sections 48 and 107A.
- Court recorded Dr. Reddy’s undertaking not to sell in India.
Next Hearing:
August 19, 2025 – Final arguments to address patent validity, infringement scope, and statutory exemptions.
Brazil – Semaglutide Protection Status
The semaglutide compound patent in Brazil expires in March 2026. Attempts by Novo Nordisk to extend this protection were denied by a federal court, upholding the 2026 expiry date
After this expiry, local and international pharmaceutical companies are positioned to release generic versions.
- Brazilian firm Hyperaplans to launch generic semaglutide immediately following the expiration.
- At least four other companies, including Biomm (partnering with Biocon of India), have filed for regulatory approvals for generic semaglutide and are preparing marketing strategies.
- Global manufacturers like Dr. Reddy’s are also set to enter from 2026 onwards.
Canada – Semaglutide Protection Status
In Canada, the compound patent for semaglutide (CA2601784) is scheduled to expire in March 2026. However, the patent has lapsed due to Novo Nordisk’s failure to pay the required maintenance fees. As a result, Novo Nordisk’s market exclusivity for GLP-1 semaglutide will end in January 2026. Under Canadian patent law, once a patent lapses for non-payment, it cannot be reinstated.
With the loss of exclusivity, several companies—including Sandoz, Apotex, Hims & Hers, and Biocon—have filed applications to launch generic versions of semaglutide as early as January 2026, pending Health Canada’s regulatory approval.
Semaglutide Generic Players: Activities for Product Launch
- Dr. Reddy’s Laboratories
- Global Strategy: Plans to launch generic semaglutide (injectable and oral forms) in 87 countries starting 2026, focusing first on India, Canada, Brazil, Turkey, and other emerging markets—pending local patent expiry.
- Legal Preparedness: Facing ongoing patent-infringement litigation with Novo Nordisk in India; manufacturing for export is permitted while local sales are paused until patent expiry or court resolution.
- Regulatory Actions: Filed regulatory applications in target launch countries and is building capacity for “high-volume, low-cost” manufacturing.
- Long-term Vision: Aims to introduce 26 GLP-1 drugs over the next decade.
- Biocon
- Product Focus: Developing generic versions of Ozempic (semaglutide, injectable) and Wegovy (for obesity/weight loss) with launches targeted for Canada and emerging markets post-patent expiry.
- Manufacturing Investments: Leveraging peptide manufacturing expertise and planning expansion into additional GLP-1 therapies.
- Cipla, Lupin, Sun Pharma, Aurobindo Pharma
- Pipeline Activities: All are actively developing semaglutide generics and scaling up manufacturing capabilities in anticipation of the 2026 patent cliff. The focus is on affordability and export to markets where legal pathways are open.
- Regulatory Steps: Filed for regulatory approvals in India and abroad.
- Zydus Lifesciences
- Manufacturing Commitment: Investing over ₹100 crore (~$12 million) in a new proprietary facility for cost-effective semaglutide production, aiming for a rapid response post-patent expiry6.
- Technology Focus: Emphasis on producing GLP-1 drugs at lower operational costs.
- OneSource Specialty Pharma
- Capacity Building: Investing $100 million in expanding manufacturing, with expectations that semaglutide could contribute significantly to future revenues6.
- Domestic/Export Strategy: Participating in India’s export-focused peptide manufacturing ecosystem due to local legal barriers until 2026.
- Divi’s Laboratories
- API Supply: Major supplier of semaglutide’s active ingredient, reporting significant growth in peptide business. Key to the global supply chain for both generic and innovator formulations.
- Chinese and International Entrants
- China: Companies like Hangzhou Jiuyuan Gene Engineering (Huadong Medicine) are expected to be among the first to launch semaglutide biosimilars after China’s patent expiry in March 2026. Multiple Chinese firms are conducting late-stage trials and regulatory filings.
- Other Global Players: Sandoz Group AG and various international suppliers are positioned to enter as market exclusivity lapses in their regions.
- API Exporters: Numerous firms across India, China, and Europe are gearing up to supply the semaglutide API globally to both branded and generic market entrants.
For a complete product landscape of Semaglutide, access ChemRobotics PharmVetPat Ultimate API – Generic Suite.
References:
- Novo Nordisk. (2025). News details – Wegovy sales and corporate update. Retrieved from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=915995
- Pharmaceutical Technology. (2025). Novo Nordisk cuts 2025 outlook due to compounding hit, Wegovy demand. Retrieved from https://www.pharmaceutical-technology.com/news/novo-nordisk-cuts-2025-outlook-due-to-compounding-hit-wegovy-demand/?cf-view
- UK Government. (n.d.). Check the Patents Journal. Retrieved from https://www.gov.uk/check-the-patents-journal
- National Center for Biotechnology Information (NCBI). (2023). Mechanism of GLP-1 receptor agonists. In GLP-1 Receptor Agonists (Table 3). Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK602920/table/t03/
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- Reuters. (2025, July 23). India’s Dr. Reddy’s plans to launch generic obesity drugs in 87 countries next year: CEO. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/indias-dr-reddys-plans-launch-generic-obesity-drugs-87-countries-next-year-ceo-2025-07-23/
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- The Economic Times. (2025). India GLP-1 weight loss drugs: Mounjaro, Wegovy, semaglutide patent expiry opens up market. Retrieved from https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/india-glp1-weight-loss-drugs-mounjaro-wegovy-semaglutide-patent-expiry-obesity/articleshow/122829113.cms
- Financial Express. (2025). India to soon get cheaper versions of weight-loss drug – all you need to know. Retrieved from https://www.financialexpress.com/business/healthcare-india-to-soon-get-cheaper-versions-of-weight-loss-drug-all-you-need-to-know-3884093/
- Center for Biosimilars. (2025). Eye on pharma: Biosimilar Ozempic, Biocon-Mylan merger, Celltrion omalizumab submission. Retrieved from https://www.centerforbiosimilars.com/view/eye-on-pharma-biosimilar-ozempic-biocon-mylan-merger-celltrion-omalizumab-biosimilar-submission
- Clarivate. (2025). What a string of semaglutide biosimilars could mean for mainland China. Retrieved from https://clarivate.com/life-sciences-healthcare/blog/what-a-string-of-semaglutide-biosimilars-could-mean-for-mainland-china/
- Pharmaceutical Technology. (2025). Brazilian federal court denies semaglutide patent extension. Retrieved from https://www.pharmaceutical-technology.com/pricing-and-market-access/brazilian-federal-court-semaglutide-patent-extension/?cf-view
- Visible Alpha. (2025). GLP-1 Drug Monitor: Blockbusters and up-and-comers. Retrieved from https://visiblealpha.com/blog/visible-alpha-glp-1-drug-monitor-blockbusters-up-and-comers/