In patent fight versus Pfizer generic, Astellas gets good news and bad

Fourteen years after it launched Lexiscan in the U.S., Astellas is trying to wring the last bit of market exclusivity it can get out of the scanning agent.

In federal court last week in Delaware, Astellas got good news and bad in its attempt to keep Pfizer’s generics unit Hospira from launching its generic version of Lexiscan, which is used in patients who don’t have the physical ability to undergo a cardiac stress test.

While the court granted Astellas an interim injunction that prevents Hospira from launching its copycat until Oct. 5, it also rejected the company’s bid for a preliminary injunction, which would have prevented the launch until the case works its way through U.S. appeals court.

Now, it is up to Hospira to decide whether to launch its generic and risk exposure to damage claims should Astellas eventually emerge with an appeals win. Astellas claims that Hospira is infringing three patents with its formulation.

In May, the court ruled that Hospira’s generic does not infringe the patents Astellas holds for Lexiscan. The patents, which are owned by Gilead Sciences, are licensed to Astellas. The companies are awaiting a date for the appeal’s hearing.

Lexiscan (regadenoson injection) is an adenosine receptor agonist used in myocardial perfusion imaging. It generated approximately $650 million in sales in the 12 months that ended March 31 of this year.

Several other Lexiscan generics have been approved this year, including versions made by Apotex, Accord, Dr. Reddy’s, Hong Kong, Glenmark and Amphastar.