Lupin Limited (Lupin) announced today that its wholly owned subsidiary in Australia, Generic Health Pty Ltd, has received approval for Tiotropium 18 micrograms powder for inhalation in capsules for use with LupinHaler, its bioequivalent version of SPIRIVA tiotropium (as bromide monohydrate) powder for inhalation from Therapeutic Goods Administration (TGA). The product will be manufactured at Lupin's Pithampur facility in India.

Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsules for use with LupinHaler is indicated for the long-term maintenance treatment of bronchospasm and dyspnea associated with chronic obstructive pulmonary disease (COPD) and for the prevention of COPD exacerbations.

"We are pleased to have received the approval for bioequivalent Tiotropium Dry Powder for Inhalation from TGA for the treatment of COPD in Australia. This will provide a high-quality and lowcost treatment option to healthcare professionals in Australia for the treatment of COPD. This approval is an important milestone in our commitment to enable access to medicines and offer affordable options of complex generics for patients in Australia, particularly in the respiratory therapeutic area," said Dr. Sofia Mumtaz, President - Legal, Canada, Australia, and Japan.

Tiotropium Bromide Inhalation Powder (Reference Product Spiriva) had estimated annual sales of USD 10 million in Australia (IQVIA MAT Mar 2023).