On 5 August 2026, Novo Nordisk announced that The Hague District Court granted a preliminary injunction (PI) preventing Ceban Ziekenhuisfarmacie B.V. (a retail pharmacy based in the Netherlands) from selling a compounded semaglutide nasal spray under the name Semanova.  To date, no nasal spray formulations of semaglutide have been given regulatory approval anywhere in the world.

Novo Nordisk’s European compound patent for semaglutide (EP 1 863 839) expired in March 2026.  In the Netherlands, Novo Nordisk holds a supplementary protection certificate (SPC) extending patent protection over semaglutide until 19 March 2031.

The court found that Ceban’s nasal spray infringed Novo Nordisk’s Dutch SPC for semaglutide.  As a result, the court has ordered Ceban to cease the infringing activities, remove product listings, disclose commercial supply chain information and reimburse Novo Nordisk’s legal costs.

According to JUVE Patent, Ceban’s defence relied on the pharmacy compounding exemption under Article 54c(e) of the Dutch Patent Act, which permits small-scale compounding for individual patients pursuant to a medical prescription.  The court found that Ceban’s resale of nasal sprays to other pharmacies and registration in the Dutch drug database fell outside of this exemption.

In Europe, Novo Nordisk markets semaglutide as Wegovy® for weight loss (subcutaneous injectable (0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg standard dose or 7.2 mg high dose) or oral pill), and as Ozempic® (once-weekly subcutaneous injectable) and Rybelsus® (once-daily oral pill) for the treatment of type 2 diabetes.

Generic semaglutide products are yet to launch in Europe but have launched in India in March 2026 (including by Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark) and Canada in May 2026 (by Apotex and Dr Reddy’s).  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents and subject to ongoing US patent infringement litigation.

On 29 July 2026, Sandoz announced that Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has approved Owozy® (semaglutide), a generic version of Novo Nordisk’s Ozempic®, for type 2 diabetes.  Sandoz is expecting to launch the product in the second half of 2026.

Owozy® was developed by Malta-headquartered Adalvo and will be commercialised in Brazil by Sandoz in a pre-filled, multi-dose disposable pen.  The Brazilian market for GLP-1 is estimated to be worth USD 1.8 billion, with more than 16.5 million Brazilians living with diabetes.

The Brazilian approval comes just weeks after Sun Pharma’s generic semaglutide injection was approved in South Africa (announced 15 July 2026), with launch following shortly thereafter.  A number of generic semaglutide products have also launched in India and Canada.  In March 2026, Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark launched generic semaglutide products on the Indian market, following the expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.

Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.  Novo Nordisk has sued Apotex in the US in relation to generic Rybelsus®, Ozempic® and Wegovy®, alleging patent infringement, with the three cases being consolidated in June 2026.  Novo Nordisk also commenced Hatch Waxman litigation against Cipla in July 2026 in relation to generic semaglutide products.

Novo Nordisk has commenced Hatch-Waxman litigation in the US against both Cipla and Apotex in relation to their generic versions of Novo Nordisk’s semaglutide products.

Most recently, on 17 July 2026, Novo Nordisk filed a Complaint against Cipla in the US District Court for the District of New Jersey alleging that Cipla’s generic version of Novo Nordisk’s Ozempic® (semaglutide) infringes four US patents which cover Ozempic® and/or its use: US 8,129,343, US 10,335,462, US 12,295,988 and US 12,569,543.  The complaint arises from Cipla’s submission of an Abbreviated New Drug Application (ANDA) seeking approval to market generic Ozempic® in dosage strengths of 2 mg/3ml, 4 mg/3ml and 8 mg/3ml.

Novo Nordisk had previously commenced litigation in the same Court against Apotex on 10 October 2024 in relation to generic Rybelsus® (semaglutide), on 20 February 2026 in relation to generic Ozempic® tablets® and on 29 April 2026 in relation to generic Wegovy® (semaglutide).  Orders were made by the Court on 12 June 2026 consolidating the three actions.  Apotex received the first US FDA Tentative Approval for its generic Ozempic® ANDA in April 2026, signifying that Apotex’s product meets all statutory and regulatory requirements for approval but cannot be marketed in the US because of patents or exclusivities related to the reference drug.

Novo Nordisk also has patent litigation pending in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan in relation to generic Wegovy®, which was commenced in September 2024.

Meanwhile, on 21 July 2026, Novo Nordisk filed a false advertising lawsuit against Eli Lilly in the US District Court for the District of New Jersey, alleging that Eli Lilly’s nationwide, direct-to-consumer advertising campaigns for GLP-1 medicines are designed to mislead the public about the comparative effects of those medicines for weight loss and type 2 diabetes.

Novo Nordisk claims that Eli Lilly’s ads falsely tell consumers that Zepbound® (tirzepatide) helps patients lose significantly more weight than Novo Nordisk’s Wegovy® and that Eli Lilly’s Mounjaro® (tirzepatide) reduces a key measure of blood sugar control for type 2 diabetes patients significantly more than Novo Nordisk’s Ozempic®.  According to Novo Nordisk, in both cases, the ads are false and misleading because Eli Lilly seeks to support its representations with outdated clinical trials that compare the highest dose of Zepbound®/Mounjaro® to lower doses of Novo Nordisk’s medicines, when there are newer, more effective does of Novo Nordisk’s products available.

Novo Nordisk is seeking preliminary and permanent injunctions preventing Eli Lilly from continuing to disseminate the comparative advertising, as well as damages and corrective advertising.

On 15 July 2026, Sun Pharma announced that the South African Health Products Regulatory Authority (SAHPRA) has approved its semaglutide injection, generic equivalent of Novo Nordisk’s Ozempic® (semaglutide) for the treatment of adults with type 2 diabetes mellitus.  The launch is expected to occur in the coming days.

The semaglutide injection was approved as a pre-filled, multi-dose injectable pen in two strengths (2 mg/1.5 mL and 4 mg/3 mL) for once-weekly treatment of adult patients as an adjunct to diet and exercise.  This is the second market to date, following India, where Sun Pharma’s generic semaglutide has received approval.

On 18 July 2026, Business Insider Africa announced that Novo Nordisk is partnering with Swiss pharmaceutical company, Acino, to launch Extensior™, a lower-cost version of Ozempic® (semaglutide) on 27 July 2026 in South Africa.  Extensior™ will be available in 0.25mg, 0.5mg and 1mg doses in the same injection device as Ozempic®.  This followed Novo Nordisk securing an interim order from the Gauteng High Court preventing iDexis from manufacturing and selling compounded semaglutide medicines in South Africa in June 2026.  iDexis has appealed the court order and decisions made by SAHPRA and the South African Pharmacy Council.

A number of generic semaglutide products have already launched in India and Canada.  In March 2026, Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark launched generic semaglutide products on the Indian market, following the expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

Novo Nordisk has recently launched alternative semaglutide formulations globally.  Novo Nordisk’s Wegovy® pill was the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU.  Marketing authorisation for the Wegovy® pill and Wegovy® 7.2mg injection in a single-dose pen was granted by the European Commission on 15 July 2026.  This followed the first-in-world US approval of the oral formulation by the FDA on 23 December 2025 and US launch of the Wegovy® pill on 5 January 2026.

On 29 June 2026, Health Canada approved Apotex’s Sevmia™, generic equivalent of Novo Nordisk’s Wegovy® (semaglutide).  Sevmia™ is the first generic semaglutide product approved in Canada for chronic weight management.

Sevmia™ was developed in partnership with Orbicular Pharmaceutical Technologies and is approved as a solution for subcutaneous injection in a pre-filled pen (4 mg/pen; 1.34 mg/mL).  It is indicated for once-weekly treatment of patients aged 12 years and over, as a supplement to a reduced calorie diet and increased physical acitivity for chronic weight management.

Generic semaglutide products have previously been approved in Canada only for the treatment of type 2 diabetes.  Apotex’s Apo-Semaglutide Injection™ was approved on 1 May 2026 and launched 14 May 2026, while Dr Reddy’s Laboratories’ generic semaglutide injection was approved on 29 April 2026 and also launched in Canada on 14 May 2026.

Health Canada is reviewing numerous submissions for generic semaglutide, including applications by AA Pharma, Aspen Pharmacare, Teva, Taro Pharmaceuticals, Zydus Lifesciences and Sandoz (which is planning a 2026 generic semaglutide launch in Canada).  Further generic semaglutide approvals and launches are therefore expected in Canada in the coming months.

On 10 June 2026, Gedeon Richter and Indian-headquartered Hetero Labs announced that they have entered a global collaboration agreement to jointly develop, register and commercialise a generic semaglutide injection, referencing Novo Nordisk’s Ozempic®.  The companies are intending to submit EU and US regulatory filings in 2027.

The collaboration aims to take advantage of Hetero’s market reach in the US and emerging markets and Richter’s commercial infrastructure across Europe and Central Asia, while retaining the option for Richter to manufacture in Europe in future.

Numerous generic semaglutide products launched on the Indian market in March 2026, including by Dr Reddy’s Zydus, Alkem, Sun Pharma and Glenmark, following expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

On 22 and 23 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two new formulations of Novo Nordisk’s semaglutide:

• Wegovy® pill (once-daily oral semaglutide 25 mg); and
• high-dose Wegovy® 7.2 mg (once-weekly injectable semaglutide) in a single-dose pen formulation,

The Wegovy® pill is the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU. It follows the first-in-world US approval of the oral formulation by the FDA on 23 December 2025 and US launch of the Wegovy® pill on 5 January 2026.  Eli Lilly’s Foundayo™ (orforglipron), the only other oral GLP-1 receptor therapy for weight loss, received US FDA approval on 1 April 2026 and became available to patients on 6 April 2026.

High dose Wegovy® expands the dosing options available in Europe, with Wegovy® currently available only as once-weekly treatment with three separate 2.4 mg injections administered one after each other.  Novo Nordisk expects to launch Wegovy® 7.2 mg in a single-dose pen in Q3 2026 in Europe.  Wegovy® 7.2 mg is already available in the US under the brand name Wegovy® HD.

On 20 May 2026, The Economics Times reported that Zydus Lifesciences plans to commercialise its generic semaglutide formulation across more than 20 markets over the next two years.

Zydus was one of the first companies to launch generic semaglutide in India (marketed as Semaglyn™, Mashema™ and Alterme™) upon expiry of Novo Nordisk’s key Indian semaglutide patent in March 2026.  Under agreements announced in March 2026, Lupin holds semi-exclusive rights to co-market Zydus’ semaglutide injection in India under the brand names Semanext® and Lupin’s Livarise®, while Torrent Pharmaceuticals holds semi-exclusive rights to co-market the product in India under its own brand name Sembolic™.

Zydus now has global partnerships and registration plans underway for other regions, subject to regulatory approvals.  Sharvil Patel, Managing Director of Zydus, stated that the company expects to “see some launches this year and some in the next year”, although he admitted that Zydus “may not be part of the first wave” of generic semaglutide launches in some markets.  However, Zydus considers its differentiated offering, including its reusable pen device, will “provide significant cost benefits to patients”.

Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

Less than one month after receiving approval for generic equivalents of Novo Nordisk’s Ozempic® in Canada, Apotex and Dr Reddy’s have launched their generic semaglutide products on the Canadian market.

Apotex announced its launch of Apo-Semaglutide Injection™ on 14 May 2026, stating that initial inventory is available and is shipping to wholesalers and that the product will be on pharmacy shelves in Canada “within the coming weeks”.  Dr Reddy’s Canadian launch announcement quickly followed on 16 May 2026, with the company stating that the launch of its “Semaglutide Injection” demonstrates “Dr Reddy’s readiness to ensure patient access following approval”.  Both products are indicated for adults with type 2 diabetes and are supplied in pre-filled pens.

Dr Reddy’s was one of the first companies to receive approval for, and launch, generic semaglutide in India (under the name Obeda™).  Meanwhile, Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

It has previously been reported that Health Canada is reviewing numerous submissions for generic semaglutide, including applications by Teva, Aspen Pharmacare, Taro Pharmaceuticals and Sandoz (which is planning a 2026 generic semaglutide launch in Canada).  Further generic semaglutide approvals and launches are therefore expected in Canada in the coming months.

Following the March 2026 launch of several generic equivalents of Novo Nordisk’s Ozempic® (semaglutide) in India and the “tentative approval” of Apotex’s generic semaglutide in the US, the first semaglutide generics have now been approved in Canada.

On 29 April 2026, Dr Reddy’s Laboratories announced that it was the first company to receive approval from Health Canada for its generic semaglutide injection for the treatment of type 2 diabetes in adults.  The approval covers two formulations: 2mg/pen (1.34mg/mL) and 4mg/pen (1.34mg/mL).  While no launch date has been announced, Dr Reddy’s has “launch plans underway”.

Days later, on 1 May 2026, Apotex announced that its Apo-Semaglutide Injection™ was approved by Health Canada.  The approval covers two prefilled pen formats: 0.25 mg or 0.5 mg doses (containing 2 mg of semaglutide 0.68mg/mL) and 1 mg doses (containing 4 mg of semaglutide 1.34 mg/mL).  Apo-Semaglutide Injection™ was developed by Apotex through a strategic partnership with Orbicular Pharmaceutical Technologies, headquartered in India.

Dr Reddy’s and Apotex are active in the generic semaglutide space, with Dr Reddy’s one of the first companies to receive approval for, and launch, generic semaglutide in India (under the name Obeda™) and Apotex receiving the first US FDA Tentative Approval for its generic semaglutide ANDA, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

It has previously been reported that Health Canada is reviewing numerous submissions for generic semaglutide, including applications by Teva, Aspen Pharmacare, Taro Pharmaceuticals and Sandoz (which is planning a 2026 generic semaglutide launch in Canada).  Further generic semaglutide approvals are therefore expected in Canada in the coming weeks and months.