Natco SA

iStock, hapabapa Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents. Novo Nordisk and Viatris subsidiary Mylan on Monday reached a settlement in their patent dispute over the blockbuster incretin therapy semaglutide. According to a filing by Indian company Natco Pharma, the terms of the settlement are confidential, so the companies’ financial arrangements are unknown. It is also unclear when generic versions of semaglutide are allowed to enter the U.S. market. Natco is partnered with Mylan on the development of these generics. In accordance with the settlement, Novo and Viatris on Monday also submitted a joint filing to the U.S. Patent and Trademark Office (PTO) asking it to terminate all proceedings and pending motions related to the patent dispute. Novo sued Mylan in 2022 claiming patent infringement. According to the lawsuit, filed in the District Court for the Northern District of West Virginia, Mylan had filed an abbreviated New Drug Application (ANDA) for a generic version of Ozempic, the brand of semaglutide indicated for type 2 diabetes. Novo argues that in filing its ANDA, Mylan signified its intention to “sell, offer to sell, use, and/or engage in the commercial manufacture” of an Ozempic generic that would violate nearly 20 of its patents that have yet to expire. In particular, Mylan’s generic uses protected technology related to the structure of the GLP-1 drug itself, the overall formulation of the medication and the injection device, among other characteristics. The pharma at the time asked the court to prevent Mylan from manufacturing and selling its generic version, pending approval, before the expiration of any of the patents under contention, including extensions. Novo has since filed other lawsuits against Mylan, including one in July 2024 that focused on two patents —concerning the pharmaceutical composition and specific use of semaglutide in type 2 diabetes—that Mylan’s ANDA allegedly violated. Mylan, meanwhile, has challenged the validity of Novo’s patents. According to Monday’s joint document to the U.S. PTO, Mylan filed for an inter partes review in March 2023. The PTO Board started its review a few months later, in October 2023. Ozempic works by mimicking the GLP-1 hormone and activating its corresponding receptor. Through this mechanism of action, Ozempic promotes the secretion of insulin from the pancreas in response to a rise in blood sugar levels. The drug also slows gastric emptying and helps suppress appetite. Ozempic’s sister brand Wegovy is indicated for chronic weight management. Ozempic made around $14 billion in 2023 , while Wegovy earned another $4.5 billion.

After inspections in recent months, the FDA has handed out a pair of warning letters to Indian drugmakers Kilitch Healthcare India and Natco Pharma. It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. And, at the bare minimum, those workers ought to be wearing shoes. Unfortunately for Kilitch Healthcare India, those simple standards weren’t upheld when inspectors from the U.S. FDA visited the company’s plant in Navi Mumbai, India, in October. The FDA came out swinging against Kilitch in a four-observation warning letter this week, blasting the company for keeping its manufacturing facility “in a state of disrepair, poorly cleaned and maintained.” FDA officials pointed to residue on HEPA filters, instances of operators using “visibly dirty” restricted access barrier systems to make adjustments on the filling line and—perhaps most egregiously—“multiple barefoot employees” who were handling materials being transferred to a production area. The regulatory rebuke follows an inspection of Kilitch’s facility in Navi Mumbai from Oct. 12 to Oct. 20, 2023. Investigators issued the warning letter late last month after Kilitch failed to clean up its act following the receipt of a Form 483. Breaking down the FDA’s specific observations, the agency chided Kilitch for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses. In light of Kilitch’s manufacturing deviations, the FDA has recommended the company enlist a production consultant. For its part, Kilitch has told the regulator it has suspended all production of drugs bound for the U.S. market. Now, the FDA wants to know whether Kilitch eventually plans to resume manufacturing for the U.S. from its Navi Mumbai factory. Elsewhere, India's Natco Pharma received (PDF) its own FDA warning letter this week following an inspection of its Kothur plant in Telangana, India, according to a company filing on the Bombay Stock Exchange Tuesday. Details on the FDA’s specific observations were sparse, with Natco stressing that it doesn’t believe the write-up will disrupt supply flow or existing sales from the facility. That said, the warning letter could delay or scupper pending product approvals from the site, Natco said. Natco added that it will respond to the letter promptly and address the FDA’s concerns in a “holistic and timely manner.” The FDA has distributed warning letters to a number of other companies this year, such as China’s Deebio Pharmaceuticals and Mexico’s Glicerinas Industriales.

PARSIPPANY, N.J.--( BUSINESS WIRE )--Natco Pharma Limited, a research and development (R&D)-focused pharmaceutical company based in India, today announced that DASH Pharmaceuticals, a company that markets, sells, and distributes generic pharmaceutical products, has officially transitioned to Natco Pharma USA, the U.S. subsidiary of Natco Pharma. As of January 2, all products marketed by the company will transition to the Natco Pharma USA label, with no changes to the current NDC Numbers. Natco Pharma USA is led by Subba Rao Mente, Chief Executive Officer. Julie Trendowicz and Nick DiMaio, the former Executive Vice President and President of DASH, respectively, will assume the same roles under Natco Pharma USA. “ By acquiring DASH, Natco Pharma has gained a strategic presence in the United States, connecting us directly with our valued customers in this crucial market,” said Subba Rao Mente, Chief Executive Officer of Natco Pharma USA. “ This strategic move isn't just about growth; it's about bolstering our commitment to the U.S. pharmaceutical landscape.” Since 2007, Natco Pharma has been active in the US market, forging co-development and licensing partnerships with leading U.S. generic pharmaceutical companies. The company’s collaborative efforts have culminated in the successful development and launch of a range of first-to-market generics and complex formulations, including Lenalidomide Capsules, Glatiramer Acetate Pre-Filled Syringes, Liposomal Doxorubicin Vials, Oseltamivir Phosphate Capsules, Lanthanum Carbonate Chewable Tablets, Everolimus Tablets, and Lapatinib Tablets. These launches have firmly established Natco Pharma as a formidable and trustworthy entity in the U.S. generic pharmaceutical industry, laying the groundwork for a large-scale expansion into the U.S. With the establishment of Natco Pharma USA, the company hopes to continue to increase accessibility and affordability of its generic products. About Natco Pharma Limited Natco Pharma Limited (Natco Pharma) is an R&D-focused pharmaceutical company based in Hyderabad, India, with subsidiaries in North America, Latin America, Australia, and Southeast Asia. With nearly 4,500 employees worldwide, the company develops, manufactures, and markets Finished Dosage Formulations (FDF) and Active Pharmaceutical Ingredients (APIs) with a focus on niche therapeutic areas and complex products. The company's products reach more than 40 countries globally through its own subsidiaries and partnerships, where Natco products are out-licensed to multinational companies and companies with strong local and regional presence in their respective geographies. About Natco Pharma USA Based in New Jersey, Natco Pharma USA is the U.S. Sales and Marketing company for all DASH products, as well as current, future and non-committed products developed and manufactured by Natco Pharma. The company's growing product catalog includes products across multiple therapeutic areas. Natco Pharma USA has various opportunities for collaborating, including a variety of profit-share and supply-chain initiatives such as Co-Development/Co-Ownership of ANDAs, Licensing of ANDAs, Acquisition of NDAs/ANDAs, and Authorized Generics. For more information, please visit www.natcopharmausa.com .