Phathom’s Voquezna exclusivity dispute expands with FDA consultation and another challenger

Phathom ($PHAT) said the FDA opened a public docket seeking comment on legal and regulatory questions raised by a challenge to Voquezna’s exclusivity. Comments are due by November 23. Phathom has also moved to intervene in BDR Pharmaceuticals’ lawsuit, while another prospective generic applicant, Saba Ilac, has identified a related case and said it intends to seek consolidation.

The dispute concerns the FDA’s earlier recognition of ten years of new chemical entity exclusivity, extending through May 3, 2032. The new consultation and legal steps broaden the challenge; they do not themselves revoke that protection or authorize a generic product. An adverse outcome could allow generic applications to advance sooner, making the proceedings commercially important for Phathom’s gastrointestinal franchise. Phathom maintains that the FDA’s original interpretation was correct.

Sources:

• GlobeNewswire