Phathom Pharmaceuticals Provides Update on FDA Litigation

Phathom Pharmaceuticals announced that the FDA established a public docket to solicit comments on regulatory questions regarding BDR Pharmaceuticals' challenge to VOQUEZNA's 10-year New Chemical Entity (NCE) exclusivity, which is set to expire May 3, 2032. Phathom plans to intervene in the litigation and submit comments to defend its statutory exclusivities. A second ANDA filer, Saba Ilac, has also indicated intent to consolidate its case with BDR's.