Senores Pharmaceuticals acquires USFDA-approved Roflumilast ANDA from Breckenridge Pharmaceutical
Acquisition aligns with Senores’ strategy to expand into chronic bronchitis treatment and specialty distribution in the US market
Senores Pharmaceuticals (SPL), through its wholly-owned subsidiary Senores Pharmaceuticals, Inc., USA (SPI), has signed an agreement to acquire the US Food and Drug Administration (USFDA)-approved Abbreviated New Drug Application (ANDA) for Roflumilast 250 mcg and 500 mcg tablets from Breckenridge Pharmaceutical, Inc. Breckenridge Pharmaceutical is a US subsidiary of Towa International that markets, distributes, and sells generic pharmaceuticals across the United States.
Roflumilast is prescribed to reduce the risk of exacerbations in patients with severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis and a history of exacerbations. According to IQVIA data, the market size for Roflumilast in the United States was approximately USD 32 million for the 12 months ending June 2024. Data from the specialty aggregator Symphony reported a market size of approximately USD 46 million for the 12 months ending September 2024.
The acquisition will be funded through proceeds raised by SPL’s Initial Public Offer (IPO), as outlined in the Objects of the IPO stated in the Red Herring Prospectus.
Swapnil Shah, Managing Director of Senores Pharmaceuticals, said, “We are excited to announce the acquisition of the Roflumilast tablet ANDA from Breckenridge Pharmaceutical, Inc. This strategic acquisition of Roflumilast Tablet ANDA, for which the manufacturing will be done locally at our US site, expands our portfolio into specialty distribution and also helps us establish a presence in the chronic bronchitis therapy area. This aligns with our strategic focus on identifying and entering a niche, under-penetrated generic formulations with an opportunity to serve the unmet needs in healthcare.”
The acquisition supports Senores Pharmaceuticals’ strategy to expand its presence in the US pharmaceutical market and strengthen its portfolio in the treatment of chronic respiratory conditions. The company aims to leverage its manufacturing capabilities in the US to meet the demand for generic formulations in specialised therapy areas.