Partner Orbicular receives ANDA approval from USFDA
Cipla USA Inc. the wholly owned subsidiary of Cipla Limited(BSE: 500087; NSE: CIPLA; and hereafter referred to as “Cipla”) today announced the launch of Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens, the generic equivalent of Saxenda® (liraglutide injection).
This milestone builds on the recent Abbreviated New Drug Approval (ANDA) by United States Food & Drugs Administration (USFDA) obtained by its partner, Orbicular, for Liraglutide Injection(generic Saxenda®). Cipla will lead the product’s marketing and distribution, enabling broad access and reliable availability for patients. The company is set to commence the launch on an immediate basis.
Liraglutide Injection is a complex injectable peptide delivered through a multidose injector pen drug-device combination. It is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients meeting defined clinical criteria.
Commenting on the launch, Achin Gupta, Global CEO & MD Designate, Cipla, said, “This development represents a key milestone in our peptide portfolio and strengthens our differentiated U.S. offering. We remain focused on expanding access to high-quality, affordable medicines at scale, supported by disciplined execution and collaboration.”
Marc Falkin, CEO, Cipla North America, added: “We appreciate Orbicular’s work in achieving FDA approval, which enables our immediate U.S. launch. With Cipla’s strong commercial infrastructure and deep channel relationships, we are positioned to drive broad availability for customers and patients. This milestone strengthens Cipla’s position as one of the few companies offering generic versions of both Victoza® and Saxenda® in the U.S.”
GLP-1 receptor agonists have emerged as one of the fastest-growing therapeutic classes globally, driven by the rising prevalence of obesity and metabolic disorders, strong clinical outcomes, and increasing physician adoption.
According to IQVIA MAT December 2025, the total addressable market opportunity for GLP-1 therapies in weight management in the U.S. was approximately USD 127 million.
About Glucagon-Like Peptide-1 (GLP-1)
Glucagon-like peptide-1 (GLP-1) therapies help regulate blood glucose levels and promote weight loss by enhancing insulin secretion, suppressing glucagon release, delaying gastric emptying, and reducing food intake–supporting improved metabolic control and weight management outcomes.
About Liraglutide
Liraglutide is a synthetic analog of the human GLP-1 hormone and is administered as a once-daily subcutaneous injection. The molecule was first approved for medical use in the European Union in 2009 and in the United States in 2010. Liraglutide received U.S. FDA approval for chronic weight management in adults in 2014, with subsequent approvals in defined pediatric populations.
About Cipla Limited
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, antiretroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Dec’25), 2nd Largest in the pharma prescription market in South Africa (IQVIA MAT Nov’25), and 3rd largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Dec’25). For nine decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.
About Orbicular Pharmaceuticals, Inc.
Orbicular Pharmaceuticals Pharmaceutical Technologies Pvt. Ltd. Is a specialty pharmaceutical company focused on developing and securing regulatory approvals for technologically advanced, challenging products in complex generics. Orbicular is the ANDA holder for generic liraglutide injection.
Disclaimer
This press release contains forward-looking statements based on current expectations and beliefs of management. Actual results may differ materially due to risks and uncertainties, including market conditions, supply dynamics, and commercialization execution. Cipla undertakes no obligation to update any forward-looking statements.
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