Bausch Health to appeal expected court ruling on Xifaxan patents

Yesterday, Bausch Health Companies Inc.’s BHC shares closed. 50% lower after the patent litigation injunction reports on Xifaxan (rifaximin).

The company’s stock gained slightly after it said it would appeal a decision likely to invalidate patents related to Xifaxan.

“We are disappointed with today’s development. We strongly disagree with the conclusion that our patents are invalid and plan to appeal such an order,” said Thomas Appio, CEO of Bausch Health.

The U.S. District Court of Delaware has issued an oral injunction in the case of Salix Pharmaceuticals Ltd, the company’s gastroenterology division, et al. v. Norwich Pharmaceuticals Inc regarding the infringement and validity of certain U.S. patents of Xifaxan for the irritable bowel syndrome with diarrhea (IBS-D) and reducing the risk of recurrence of overt hepatic encephalopathy (HE).

The court will invalidate Xifaxan patents related to IBS-D, while saying it upholds the HE claims.

Related: Why Bausch Health’s Market Cap Is Being Halved: ‘A Near Worst Case Scenario’

The heart of the matter is Norwich Pharmaceuticals Abbreviated New Drug Application (ANDA) for a generic Xifaxan.

Bausch said it expects the court to impose Norwich’s ANDA until the HE patents expire in 2029. If Norwich removes HE safety data to avoid the patents, the company said it would “firmly oppose” the move.

“The FDA has stated that they plan to substantially revise the product-specific guidelines for rifaximin to add an in vivo bioequivalence study,” Bausch said.

“Until approval of a revised ANDA is granted by the FDA and the expected injunction is amended by the court, Norwich will not be allowed to market a generic equivalent of Xifaxan.”

Price Action: BHC shares are up 8.82% to $5.55 during the premarket session on the last check Friday.

Photo via Wikimedia Commons

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