Court upholds Bausch Health victory in Xifaxan fight; Norwich generic blocked until 2029
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A U.S. District Court judge in Delaware has denied Norwich Pharmaceuticals’ motion to modify the court’s final judgment, which blocks the FDA from approving their 550 mg rifaximin generic until Oct. 2, 2029.
This decision by Judge Richard G. Andrews bolsters his previous ruling that Norwich’s abbreviated new drug application for rifaximin infringed on Bausch Health’s Xifaxan (rifaximin) patents for the reduction in risk of hepatic encephalopathy (HE) recurrence.
In his final judgement, Andrews “ordered the FDA not to approve the ANDA before the latest expiration (in about 2029)” of Bausch Health’s infringed patents. Following an appeal, Norwich claimed to have removed the HE indication from its ANDA — leaving only the indication for irritable bowel syndrome with diarrhea — and filed for the court to amend its decision to allow the FDA to approve their ANDA before 2029. The court denied the motion and upheld its final judgement.
“This decision is important for patients who continue to depend on a proven and highly effective drug to treat gastrointestinal disorders,” Thomas J. Appio, CEO of Bausch Health, said in a press release. “It is our long-standing position that the Xifaxan patent claims are valid and infringed by Norwich’s ANDA. We will continue to advocate for the safety of patients who have benefited from the continued access to Xifaxan, and we look ahead to the appeal process.”
The Salix Pharmaceuticals arm of Bausch Health and Norwich have been embroiled in a legal battle since 2020 over Norwich’s proposed 550 mg rifaximin generic. Salix contends that the Norwich generic infringed on six Xifaxan patents for the manufacturing process (U.S. Patent No. 7,902,206), crystalline forms of rifaximin (U.S. Patent No. 7,045,620), the treatment of bacterial infections (U.S. Patent No. 7,915,275), and the methods of maintaining HE remission (U.S. Patent No. 8,642,573, U.S. Patent No. 9,629,828 and U.S. Patent No. 10,314,828).
In his memorandum order, Andrews highlighted Norwich’s argument that, due to their legal action, their product is “now worse off” than other Xifaxan generics that have reached settlement with Salix and will be permitted to launch in 2028.
“While true, [Norwich] does not argue that it could not have settled and gotten the same deal as the other generics,” Andrews wrote. “[Norwich] says that it has gone to the effort of proving the asserted composition and IBS-D patent claims invalid, so other generics will be able to enter the market a lot sooner than 2028 by taking advantage of [their] accomplishments. [Norwich] suggests this is inequitable (and perhaps it is), but the inequity does not exist between [Salix] and [Norwich]. To the extent there is inequity, it is between [Norwich] and other generics.”
He added: “What [Norwich] seeks is unprecedented in an ANDA case. I am hesitant to be the first, because it just seems wrong to me that [Norwich] can litigate a case through trial and final judgment based on a particular ANDA, and then, after final judgment, change the ANDA to what it wishes it had started with, and win in a summary proceeding.”
Reference:
- Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc. No. 20-430-RGA (U.S. District Court for the District of Delaware 2023). Available at: https://www.govinfo.gov/content/pkg/USCOURTS-ded-1_20-cv-00430/pdf/USCOURTS-ded-1_20-cv-00430-3.pdf. Filed May 17, 2023. Accessed May 19, 2023.
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