On 2 June 2025, Biocon announced that its generic liraglutide has been approved by India’s Central Drugs Standard Control Organisation (CDSCO) in 6 mg/ml solution for injection in pre-filled pen and cartridge.

Biocon’s liraglutide, the generic version of Novo Nordisk’s Victoza®, is indicated for the treatment of insufficiently controlled Type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise.  The CDSCO approved Biocon’s liraglutide under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities.

Biocon’s liraglutide was the first generic to Victoza® to be approved in the UK in March 2024, and was subsequently launched in February 2025.  In December 2024, Biocon and its European partner, Zentiva, received approval for liraglutide in the European Union.  The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024.  Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.

On 12 March 2025, Australia’s Therapeutic Goods Administration approved three brands of Cipla’s liraglutide, making it the second approved generic to Novo Nordisk’s Saxenda® in Australia:

• CIPLA LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen (424371)
• LIRAGLUTIDE SANDOZ: liraglutide 6 mg/mL solution for injection pre-filled pen (449145)
• ARX-LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen (424370)

All three brands (one of which will be marketed by Sandoz and another by Arrotex), are indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

• ≥30 kg/m² (obese); or
• ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

The approval closely trails Sun Pharma’s generic liraglutide, which was approved in Australia across three brands for the same indication on 6 March 2025.  Cipla’s liraglutide was accepted for review by the TGA in October 2023.  Freyr’s Lobezyl® remains as the only other generic liraglutide currently under review by the TGA (accepted for review in September 2024).

On 12 December 2024, the Federal Court of Australia rejected Cipla’s challenge to the patent term extension of Novo Nordisk’s liraglutide formulation patent (AU 2004290862).  As a result, the term of the AU formulation patent remains due to expire in August 2025.  The Federal Court decision has not been appealed.

On 6 March 2025, Sun Pharma’s liraglutide became the first approved generic to Novo Nordisk’s Saxenda® in Australia.  The product was approved by Australia’s Therapeutic Goods Administration (TGA) across three brands:

• Benedo: liraglutide 6 mg/mL solution for injection pre-filled pen (428573);
• Liraglutide RBX: liraglutide 6 mg/mL solution for injection pre-filled pen (428571); and
• Liraglutide Sun: liraglutide 6 mg/mL solution for injection pre-filled pen (428572).

All three brands are indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

• ≥30 kg/m² (obese); or
• ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

Sun Pharma’s generic liraglutide was accepted for review by the TGA in January 2024.  There are currently two other generic liraglutide products being reviewed by the TGA: Freyr’s Lobezyl® (accepted for review in September 2024) and Cipla’s unnamed generic liraglutide (accepted for review in October 2023).

On 12 December 2024, the Federal Court of Australia rejected Cipla’s challenge to the patent term extension of Novo Nordisk’s liraglutide formulation patent (AU 2004290862).  As a result, the term of the AU formulation patent remains due to expire in August 2025.  The Federal Court decision has not been appealed.

Adalvo’s generic liraglutide was the first to be approved in the EU in June 2024, while Biocon’s liraglutide was the first generic approved in the UK in March 2024.  Teva Pharmaceuticals launched the first authorised generic liraglutide in the US in June 2024.

On 28 February 2025, Biocon announced that it has launched its liraglutide products in the UK.  The products are generic versions of Novo Nordisk’s Victoza®, to treat type 2 diabetes, and Saxenda®, used in the treatment of weight management.  Biocon’s products are marketed under the brand names Liraglutide Biocon (gVictoza®) and Biolide (gSaxenda®).

Biocon’s liraglutide became the first UK-approved generic to Novo Nordisk’s liraglutide products in March 2024.

In December 2024, Biocon and its European partner, Zentiva, received approval for liraglutide in the European Union.  The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024.  Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.

On 5 February 2025, Novo Nordisk released its financial results for 2024, reporting a 26% sales increase (at constant exchange rates (CER)) to DKK 128.3 billion.  Sales in Novo Nordisk’s diabetes care segment (including Ozempic® (semaglutide), Rybelsus® (oral semaglutide) and Victoza® (liraglutide)) increased by 20% (CER) with its global diabetes value market share at 33.7% (constant over the last year).  Meanwhile, Novo Nordisk’s obesity care product sales (Wegovy® (semaglutide) and Saxenda® (liraglutide)) grew by 57% at CER to DKK 65,146 million, with its volume market share being 70.4%.

Recent highlights are reported to include the approval of Awiqli® (insulin icodec) in Europe (May 2024), Japan (June 2024) and China (June 2024); US approval (January 2025) and positive EU opinion (December 2024) for an update of the Ozempic® label based on the FLOW kidney trial; submission of the SOUL cardiovascular outcomes trial and STRIDE functional outcomes trial (oral semaglutide) in the US and EU; US approval (March 2024) of Wegovy® to reduce the risk of major cardiovascular events and positive EU opinion (July 2024) to reflect a risk reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either overweight or obesity without diabetes; and a positive EU opinion for a Wegovy® label expansion for obesity-related HFpEF (November 2024).

Novo Nordisk predicts sales growth of 16-24% at CER for 2025.  This is expected to be driven mainly by volume growth of GLP-1 based treatments for obesity and diabetes care, but also takes into account competition and continued pricing pressure within those markets.

On 15 January 2025, Lexaria Bioscience announced that it has received independent ethics board approval to begin its first-ever human study of oral liraglutide, formulated from the DehydraTECH-processing of conventional injected liraglutide (Novo Nordisk’s Saxenda®).

The study is expected to involve 8-10 healthy volunteers and will compare the oral formulation with the conventional injected version.  Lexaria considers this could potentially advance its DehydraTECH-processing technology as a leading drug delivery method.  According to Lexaria, successful outcomes could lead to further clinical trials, potentially impacting the market for GLP-1 drugs significantly and providing new options for patients and healthcare providers.

On 2 January 2025, the FDA published a Citizen Petition filed by Novo Nordisk seeking to exclude its type 2 diabetes liraglutide injection Victoza® from a proposed list of drugs eligible for compounding.  In its petition, Novo Nordisk argues that there is no clinical need to compound liraglutide and that it will not lend well to compounding citing safety concerns.

This follows a separate petition filed by Novo Nordisk in October 2024 requesting inclusion of semaglutide in the Demonstrable Difficulties for Compounding (DDC) list, citing safety concerns.  In November 2024, the US Alliance for Pharmacy Compounding (APC) provided a lengthy rebuttal to Novo Nordisk’s assertions arguing that synthetic semaglutide APIs are safe and rigorously regulated, often showing comparable or better impurity profiles than Novo Nordisk’s recombinant APIs.

On 26 December 2024, Hikma Pharmaceuticals announced that it has received FDA approval for, and launched, its generic version of Novo Nordisk’s Victoza® (liraglutide) in the US in a 6mg/mL dosage form.

The FDA prioritises review of generic versions of drugs that are in short supply.  Novo Nordisk’s Victoza® (liraglutide injection 1.8mg), has been on the FDA’s shortage list since July 2023.

Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.

On 24 December 2024, Biocon announced that the company and its European partner, Zentiva, have received Decentralised Procedure (DCP) approval for liraglutide in the European Union.  The approval is for the generic versions of Novo Nordisk’s Victoza®, to treat type-2 diabetes, and Saxenda®, used in the treatment of weight management.

Biocon’s liraglutide became the first UK approved generic to Novo Nordisk’s Victoza® in March 2024.  The first EU approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024.

On 24 May 2024, Biocon announced that it signed an exclusive licensing and supply agreement with Korea’s Handok Inc for the commercialisation in South Korea of its synthetic liraglutide.

On 14 May 2024, we reported that Cipla had commenced Federal Court proceedings challenging the patent term extension (PTE) to Novo Nordisk’s liraglutide formulation patent (AU2004290862).  Liraglutide is marketed by Novo Nordisk in Australia as Victoza®.  Cipla argued that the PTE was invalid on the basis that only patents for active ingredients and not patents for formulations (which included mixtures of active ingredient(s) and excipients) were eligible to be extended under the Australian PTE regime.

On 12 December 2024, the Federal Court delivered a decision rejecting Cipla’s challenge and upholding Novo Nordisk’s PTE, which extends the patent term from 18 November 2024 to 26 August 2025.

Accordingly, subject to any appeal, formulation patents continue to be eligible for PTEs in Australia.  Cipla can also no longer achieve its intended Australian liraglutide product launch date of January 2025, as the Federal Court upheld Novo Nordisk’s cross-claim seeking injunctive relief on the basis that it was not in dispute that Cipla’s product would infringe Novo Nordisk’s patent.