The US Food and Drug Administration (FDA) had granted clearance for Mylan’s abbreviated new drug application (ANDA) for this product, which is indicated to treat osteoporosis in postmenopausal women.
According to IMS Health, Ibandronate Sodium Injection, 1mg (base)/mL, packaged in 3mg (base)/3mL pre-filled glass syringes had US sales of about $18.4m for the 12 months ending 30 June 2014.
About 288 of Mylan ANDAs are still awaiting clearance from the US FDA that represent $101.3bn in annual sales, with 42 of them being potential first-to-file opportunities, signifying $27.5bn in annual brand sales, for the year ending 30 June 2014.
The company offers a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications.
Additionally, the company provides a wide range of antiretroviral therapies, upon which about 40% of HIV/AIDS patients in developing countries depend.
The company also operates one of the largest active pharmaceutical ingredient manufacturers and currently markets products in about 140 countries and territories.