Japan- headquartered innovator drug company, Takeda Pharmaceutical Company Ltd, sued Ahmedabad-based Cadila Healthcare and its US subsidiary Zydus Pharmaceuticals (USA) Inc, alleging that the Indian drugmaker is infringing upon the former?s patent by attempting to manufacture and market the generic version of Prevecid Solu Tab (Lansoprazole) in the US market.
Lansoprazole is a gastroesophageal reflux disease (GERD) drug used in cases of heartburn, esophageal irritation among others.
The drug has an annual market size of over $500 million in the US, according to the IMS data. The largest generic company in US, Teva is also in the race to bring out the generic version of this drug in the US market. Takeda Pharmaceuticals America Inc, the US subsidiary of the Japanese firm, and the French drug firm Ethypharm, S A, have filed the suit against Cadila Healthcare and its US-based subsidiary, Zydus Pharmaceuticals in district court of New Jersey.
The innovator drug firms claim that Zydus, by filing an abbreviated new drug application (ANDA) to the US Food and Drug Administration (US FDA) and seeking approval to manufacture and market lansoprazole, delayed release orally disintegrating tablets (15mg and 30 mg) prior to the expiration of the patent validity, violates their patents coverage of the drug.