Alvogen plans to fight a court decision that could significantly delay its ability to bring a generic version of Bausch Health’s Xifaxan to market, the company said.
On Friday, its subsidiary Norwich Pharmaceuticals appealed a federal district
court ruling
that held the FDA was right to grant tentative, but not final, approval to the company’s rifaximin tablets for the treatment of irritable bowel syndrome with diarrhea. The FDA declined to grant final approval because Teva, the first applicant to file for a generic version, is eligible for 180 days of marketing exclusivity, according to the opinion.
The decision marks the latest win for Bausch Health in its bid to delay generic competition to Xifaxan, a key product that accounted for almost
$2 billion
in US revenue in 2024. The court ruling, if it stands, could bar Alvogen from marketing its proposed generic until at least June 2028.
“We will persist in advocating for the well-being of patients who have greatly benefited from sustained access to Xifaxan,” Bausch Health CEO Thomas Appio said in a statement last week.
Alvogen is now appealing the case to the US Court of Appeals for the DC Circuit. A representative for the company didn’t immediately respond to a request for comment.
The drugmaker had argued the FDA should have granted it final approval because Teva’s subsidiary Actavis forfeited its 180-day exclusivity period. Actavis hasn’t actively pursued or obtained approval to market rifaximin tablets, even though it applied about 10 years ago, Alvogen said.
But in an opinion that was unsealed on Friday, the US District Court for the District of Columbia disagreed.
“All tools of statutory interpretation point, like a compass, in one direction: Actavis has not forfeited its 180-day exclusivity under the failure-to-market provision,” the district court said.
The FDA’s decision “comports with the clear text and structure” of the law and no forfeiture occurred because Actavis included the proper certifications in its application, the court said.
Teva’s Actavis is barred under a settlement agreement from entering the generic rifaximin market until January 2028, unless another applicant obtains approval and comes to market, according to Alvogen.
Alvogen “would stand to gain and maintain a significant larger share of the generic rifaximin market for IBS-D than if it launches as just one of several generic alternatives. Such loss of market share constitutes irreparable harm,” the company had alleged in its complaint.
