Senores Pharmaceuticals Limited (SPL), through its US subsidiary Senores Pharmaceuticals, Inc. (SPI), has signed an agreement to acquire the USFDA-approved Abbreviated New Drug Application (ANDA) for Roflumilast 250 mcg and 500 mcg tablets from Breckenridge Pharmaceutical, Inc., a subsidiary of Towa International. Roflumilast is a key treatment for reducing COPD exacerbations in patients with severe Chronic Obstructive Pulmonary Disease (COPD) linked to chronic bronchitis.
The US market for Roflumilast is valued at approximately USD 32 million (IQVIA, MAT June 2024) and USD 46 million (Symphony, MAT September 2024). This acquisition, funded through SPL’s IPO proceeds, aligns with the company’s strategic goals to expand its specialty distribution portfolio and establish a presence in chronic bronchitis therapy.
Swapnil Shah, Managing Director of SPL, stated, “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”
