Cipla, an Indian pharmaceutical firm, is intensifying its efforts to become a leader in the US market for respiratory medications. The company has filed two generic respiratory drug applications with the US FDA, including a generic version of Symbicort, a medication for asthma and COPD with annual sales exceeding $3 billion. This presents a significant market opportunity for Cipla’s respiratory pipeline. Cipla is also developing several peptide-based respiratory products as part of its speciality drug focus in the US.
Cipla’s respiratory products already constitute a major share of its US generics business. Despite recent regulatory challenges, its Albuterol inhalation product continues to maintain market share, demonstrating the strength of Cipla’s position.
The company is making progress in resolving previous US regulatory observations related to its manufacturing facilities for respiratory drug production, which have hindered key drug approvals in the past.
Looking ahead, Cipla plans to file its generic Advair product application from an alternative site by mid-FY 2025. If all goes according to plan, the application could gain approval by the end of the next fiscal year.
Despite potential near-term challenges such as price erosion in the US generics market, Cipla is optimistic that its focus on respiratory medications will position it well for long-term success. The company aims to launch up to five more peptide products in FY2025, further strengthening its leadership in the US respiratory market.
Cipla’s strategic focus on respiratory medications, despite regulatory challenges, underscores its commitment to becoming a leader in the US market. Its plans to expand its product portfolio and resolve manufacturing issues reflect its long-term vision. This approach, coupled with its optimism, positions Cipla well for future success in the respiratory market.
