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.