Aurobindo Pharma enters US inhalation market with generic Advair launch

The launch marks Aurobindo Pharma's entry into the US inhalation market and expands its complex generics portfolio beyond conventional oral solid formulations

Aurobindo Pharma on Monday entered the United States (US) inhalation market with the generic version of GSK’s Advair Diskus.

 

This marks a strategic expansion of its US generics business into complex respiratory products, as the drugmaker looks to build a new growth avenue beyond conventional oral solid formulations.

 

The company, through its wholly owned subsidiary Lannett Company LLC, has launched the generic equivalent of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the US in 100/50 mcg and 250/50 mcg strengths. The product is used for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

 

For Aurobindo, the significance of the launch extends beyond the commercialisation of a single product. It is the first product from the company’s inhalation pipeline to reach the US market and provides a foothold in a segment where product development and manufacturing are more complex than conventional generics.

 

 

Inhalation products typically require specialised formulation, device and manufacturing capabilities, as well as regulatory expertise. This makes the segment relatively more difficult to enter, but also provides generic drugmakers with opportunities to build differentiated portfolios and potentially reduce dependence on highly commoditised products.

 

Aurobindo said it has multiple inhalation products under development and that the Advair launch reflects its focus on expanding its portfolio of complex and differentiated inhalation products.

 

The move is also part of the company’s broader effort to strengthen its US business through complex generics. Aurobindo has a sizable manufacturing and research and development infrastructure, with more than 30 manufacturing and packaging facilities approved by major global regulatory agencies, including the US Food and Drug Administration (USFDA).

 

The US is a key market for Indian generic drugmakers, but pricing pressure and intense competition in conventional generics have increasingly pushed companies towards complex products, where development barriers can be higher and competition comparatively limited.

 

For Aurobindo, building an inhalation portfolio could help diversify its US product mix and create a longer-term pipeline of differentiated products.