Hyderabad: Drug maker Natco Pharma Ltd on Friday said its marketing partner, Mylan Inc., has got tentative approval from the US Food and Drug Administration (FDA) for cancer drug sorafenib, the generic version of Germany-based Bayer AG’s Nexavar, in the US.
“Mylan Inc. has received a tentative approval for its abbreviated new drug application for sorafenib tablets (200mg) from the US Food and Drug Administration,” Natco said in a statement.
Sorafenib is indicated for the treatment of certain types of cancers, including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
Natco and Mylan have filed the abbreviated new drug application containing a paragraph IV certification for this product.
The company manufactures this product at its facility in Kothur, Mahaboobnagar district, in Telangana.
Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc. and Onyx Pharmaceuticals Inc. sell sorafenib tablets under the brand name Nexavar in the US market.
As per Bayer’s annual report, Nexavar had US sales of approximately $300 million for the 12 months ending 31 December 2015, Natco said.
“It’s a tentative approval, it needs to be converted into a full approval. That’s going to be based on the outcome of patent litigation,” said Afzaal Mohammed, pharma expert at Karvy Stock Broking Ltd.
If Mylan emerges successful against Bayer in the patent litigation, it will be eligible for 180-day marketing exclusivity, which means Natco, as formulation supplier, will reap a windfall, Mohammed said.
Mylan in February 2015 confirmed Bayer has filed a patent infringement suit against the company and its partner in the US district court in Delaware. The litigation is still underway.
Nexavar’s first set of patents will expire only in 2020, followed by expiration of other patents in 2024, Mohammed said.
In March 2012, Natco was granted compulsory license to manufacture and sell Nexavar by the Indian patent office for a small royalty to innovator Bayer, which held the patents, making it the first ever case of compulsory licensing in India.
Shares of Natco gained 8.54% to close at Rs.518.35 on BSE, while the benchmark Sensex ended flat at 26,843.03 points.