Generic Rival Sues FDA to Break VOQUEZNA Exclusivity Running to 2032
PHAT is trading near its 52-week low of $6.52 (5.2% above the low).
Summary
BDR Pharmaceuticals International Pvt. Ltd. sued the FDA and related Federal Defendants in the District of Columbia federal court, challenging the agency's alleged refusal to receive an ANDA referencing Phathom's NDA for VOQUEZNA and its application of the GAIN Act, which granted Phathom 10 years of new chemical entity exclusivity through May 3, 2032 for VOQUEZNA (vonoprazan fumarate) tablets. Phathom said FDA correctly evaluated the issue in its June 6, 2025 grant of Phathom's December 11, 2024 Citizen Petition recognizing that 10-year NCE exclusivity through May 3, 2032, that it is evaluating the BDR filings, and that it intends to take appropriate action to protect its statutory exclusivities. The entire thesis rests on that exclusivity window: VOQUEZNA drove Q2 2026 revenue of $74.3M, up 88% year over year, and the company just began screening patients in the Phase 3 pHalcon-NERD-302 study to expand the label. If BDR wins or the court narrows the NCE period, generic entry arrives years earlier and the revenue base is at risk; if Phathom prevails, the runway to 2032 holds.
Updated with an SEC 8-K filing · What changed
Updates
· SEC 8-K — BDR Pharmaceuticals sued the FDA in the District of Columbia federal court over its alleged refusal to receive an ANDA referencing Phathom's VOQUEZNA NDA.
- BDR Lawsuit — BDR Pharmaceuticals International Pvt. Ltd. filed suit against the FDA and related Federal Defendants in the United States District Court for the District of Columbia over FDA's alleged refusal to receive an ANDA referencing Phathom's NDA for VOQUEZNA.
- GAIN Act Challenge — BDR alleges FDA improperly applied the GAIN Act to extend Phathom's NCE exclusivity for VOQUEZNA (vonoprazan fumarate) tablets.
- Phathom Response — Phathom is evaluating the BDR filings and intends to take appropriate action to protect its statutory exclusivities.
All 5 details
- BDR Pharmaceuticals International Pvt. Ltd. filed suit against the FDA over FDA's alleged refusal to receive an ANDA referencing Phathom's NDA for VOQUEZNA.
- Suit filed against the U.S. Food and Drug Administration and related Federal Defendants in the United States District Court for the District of Columbia.
- BDR alleges FDA improperly applied the GAIN Act to extend Phathom's NCE exclusivity for VOQUEZNA (vonoprazan fumarate) tablets.
- Phathom is evaluating the BDR filings.
- Phathom intends to take appropriate action to protect its statutory exclusivities.
At the time of this announcement, PHAT was trading at $6.86 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $567.1M. The 52-week trading range was $6.52 to $18.31. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: Wiseek News.