New Delhi, March 3 NATCO Pharma announced on Tuesday the launch of generic Pomalidomide capsules in the US market, indicated for the treatment of adult patients with blood and bone marrow cancer, in partnership with Breckenridge Pharmaceutical, Inc.
Pomalidomide capsule is a generic version of Pomalyst by Celgene.
The product is available in 1mg, 2mg, 3mg, and 4mg strengths and is primarily distributed through specialty pharmacies and clinics, NATCO Pharma said in a regulatory filing.
Commenting on the launch, Vice Chairman and CEO Rajeev Nannapaneni said, "…this further strengthens our oncology and specialty portfolio in the US. The launch highlights our commitment to our mission of making specialty medicines accessible to all patients worldwide."
He further said, "We look forward to bringing more such complex and specialty products to the market in the coming years."
Breckenridge Pharmaceutical, Inc. President and Chief Commercial Officer, Brian Guy said, "Breckenridge's launch of Pomalidomide capsules delivers a high-quality, affordable generic solution, supported by copay assistance for eligible patients to help reduce treatment delays and ensure continuity of care."
Access and affordability continue to be major challenges for patients who rely on specialty therapies, Guy noted.
NATCO Pharma said Pomalidomide capsules are indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
It is also approved for AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma, the company added.
Pomalidomide Capsules, 1mg, 2mg, 3mg and 4mg, are estimated to generate sales of USD 3.2 billion in the US for the 12 months ending September 2025, according to industry sales data.
NATCO believes, based on information made available by the US Food and Drug Administration (FDA), it has 180 days of shared exclusivity for marketing the drug.