It’s near the end of the game and Astellas is running out of timeouts as it tries to stave off generic competition for its scanning agent Lexiscan.
Last week, the Court of Appeals for the Federal Circuit (CAFC) upheld a Delaware district court ruling that Pfizer’s Hospira did not infringe on patents in developing its generic version of the drug, Astellas said in a release on Wednesday.
The decision leaves Astellas with just one alternative—taking its appeal to the United States Supreme Court.
“Astellas is evaluating its legal options,” the company said. “We are also reviewing the potential financial impact for the fiscal year ending March 31, 2023.”
On Dec. 6, when the CAFC heard oral arguments in the case, a temporary stay, which had prevented Hospira from launching its generic, was lifted. In addition, the CAFC denied Astellas’ motion for an injunction pending appeal.
Pfizer confirmed the court decision but did not reveal its plans for the copycat product.
“This favorable outcome will pave the way for a future generic market for this stress agent,” the company said in a statement.
Hospira is one of several companies to have gained FDA approval for a generic version of the product. Others include Acord, Apotex, Dr. Reddy’s, Eugia, Gland and Meitheal.
Lexiscan, then owned by CV Therapeutics, was originally approved by the FDA in 2008 before it was sold to Gilead in 2009. It is used on patients who don’t have the physical ability to undergo cardiac stress tests on a treadmill. Astellas reported Lexiscan sales of $650 million for the 12 months ending on March 31 of last year.
Hospira first filed for approval of its copycat in 2018. The three patents in question are owned by Gilead and were licensed to Astellas.