According to reports from CNBC TV18, ScanXNews, Reuters, and Moneycontrol, Natco Pharma has announced the launch of Pomalidomide Capsules, a generic version of Pomalyst, in the US market. This product, developed in partnership with Breckenridge Pharmaceutical, Inc., is 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 last therapy. The capsules are 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 capsules are available in four strengths: 1mg, 2mg, 3mg, and 4mg and are distributed primarily via specialty pharmacies and clinics. As per Breckenridge Pharmaceutical, the product is available only through a restricted program called PS-Pomalidomide REMS.
As reported by CNBC TV18, ScanXNews, Reuters, and Moneycontrol, the estimated sales for Pomalidomide in the US for the year ending September 2025 was approximately $3.2 billion. Natco Pharma has indicated that it holds 180 days of shared exclusivity for this product as per FDA guidelines. This exclusivity period provides the company with a competitive advantage in the market for this specialized medication, strengthening its oncology and specialty portfolio in the US market. The launch significantly boosts Natco's footprint in the US pharmaceutical landscape, particularly in the high-value oncology segment, offering substantial revenue opportunities. With this launch, more patients could get access to life-changing treatments without breaking the bank.
According to latest reports, Natco Pharma and Breckenridge Pharmaceutical, Inc. had previously received final USFDA approval for Pomalidomide Capsules in November 2020, following a settlement of patent litigation with Celgene (now Bristol-Myers Squibb). While Natco and Breckenridge were previously named defendants in an antitrust lawsuit concerning Pomalidomide (POMALYST) capsules, they were voluntarily dismissed from the case in December 2023, with all claims against them dismissed. The company has a history of launching complex generics in regulated markets, focusing on oncology and specialty pharmaceuticals, with this launch reinforcing its expertise in developing and commercializing complex generic drugs.
According to Moneycontrol, Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer of NATCO Pharma, stated that "We are pleased to launch Pomalidomide Capsules in the US. This further strengthens our oncology and specialty portfolio in the US. The launch highlights our commitment to making specialty medicines accessible to patients worldwide. We look forward to bringing more complex and specialty products to the market in the coming years." The CEO emphasized that the launch highlights the company's commitment to making specialty medicines accessible to patients worldwide, with expectations to bring more such complex and specialty products to the market in the coming years.
As reported by Moneycontrol, Natco Pharma shares closed ₹956.40, down ₹31.90 or 3.23% in the previous trading session, with the stock touching a 52-week high of ₹1,059.60 and a 52-week low of ₹660.05 on July 24, 2025 and April 7, 2025 respectively. The stock is currently trading 9.74% below its 52-week high and 44.9% above its 52-week low, with a market capitalization of ₹17,130.07 crore. The launch significantly strengthens Natco's oncology and specialty drug portfolio within the vital U.S. market, aligning with its mission to enhance access to specialty medicines globally. The development mirrors the strategic focus of several Indian peers in the US oncology generics space, with companies like Lupin Limited, Dr. Reddy's Laboratories, Cipla, and Sun Pharmaceutical Industries all actively launching specialty and oncology drugs in the US market, which is valued at approximately $145 billion and growing at a CAGR of around 11%.
