Cipla's United States Food and Drug Administration (USFDA) approval for its generic Advair Diskus has shifted the Street's attention from regulatory progress to commercial execution.
Brokerages believe the approval is an important step towards meeting the company's FY27 US guidance, with the size of the opportunity now hinging on how quickly Cipla scales up in a competitive respiratory market.
What Did Brokerages Say?
JPMorgan
- Maintained Overweight with a target price of Rs 1,600.
- Said the approval marks Cipla's first dry powder inhaler (DPI) approval from its US manufacturing facility.
- Believes the market remains competitive but is sizeable and stable.
- Said the company is moving in the right direction to achieve its FY27 guidance.
- Added that execution will remain the key monitorable.
Kotak Securities
- Maintained Buy with a target price of Rs 1,675.
- Said the generic Advair approval marks another milestone towards achieving Cipla's US guidance.
- Expects the product to generate $22 million in FY27 and $28 million in FY28 US sales.
- Continues to rate Cipla among its top picks in the pharmaceutical sector.
FDA Approval Marks A Key Milestone
Cipla said it has received US FDA approval for its Abbreviated New Drug Application (ANDA) for generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) across all three dosage strengths.
The therapy is a generic version of Advair Diskus, which is used to treat asthma and chronic obstructive pulmonary disease (COPD). According to IQVIA, the US market for the product is valued at approximately $908 million.
The approval also marks Cipla's first dry powder inhaler approval from its US-based manufacturing network, a milestone that strengthens its complex respiratory manufacturing capabilities in the country.
Managing Director and Global CEO Achin Gupta said the approval reinforces Cipla's commitment to expanding access to complex respiratory therapies in the US through its integrated inhalation platform.
Meanwhile, Marc Falkin, CEO of Cipla North America, said the approval reflects the company's investments in building differentiated inhalation manufacturing capabilities and will help ensure a reliable supply in an important therapeutic category.
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