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.