- Bausch Health Companies ( NYSE: BHC ) said its travelers' diarrhea drug Xifaxan's patent protection is till July 24, 2029 and thus a tentatively approved generic version of the drug developed by Norwich Pharmaceuticals' is not expected to hit the U.S. market until then.
- Bausch said the U.S. Food and Drug Administration's (FDA) had granted tentative approval to Norwich rifaximin 200 mg product. The company believes it was a Paragraph III filing, which is made when an Abbreviated New Drug Application (ANDA) applicant does not intend to market its generic product until the patent expiration.
- The FDA will thus not grant full approval until the expiry of the last of Bausch's Orange Book patents for the Xifaxan (rifaximin) 200 mg product on July 24, 2029, the company said in a Sept. 9 press release.
- BHC +1.49% to $6.80 premarket Sept. 9
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Bausch expects Xifaxan patent to hinder generic entry in US until 2029 despite approval