In a move that underscores the strategic significance of regulatory exclusivity in the pharmaceutical industry, the FDA has granted Phathom Pharmaceuticals a full 10-year exclusivity for their drug Voquezna. This remarkable decision was triggered by a citizen petition asserting that Voquezna, embodying the active moiety vonoprazan, similarly found in the previously approved Voquezna Triple Pak and Dual Pak, rightly deserves the same exclusivity period. The Voquezna Paks had previously been awarded the Qualified Infectious Disease Product designation, thus benefiting from a total of 10 years of exclusivity under the FDA’s umbrella policy. This policy enables subsequent products with the same active moiety to enjoy the same exclusivity period, independent of their individual designation. This development serves as a strong testament to the importance of maintaining a potent portfolio of innovative drugs in the continually evolving pharmaceutical landscape. Phathom Pharmaceuticals’ shares have witnessed a significant surge, reflecting the investor’s renewed confidence in the company’s long-term revenue prospects tied to its acid-suppressing product line. This decision by the FDA is a monumental regulatory win for the company, as the 10-year exclusivity effectively safeguards Phathom from generic competition until 2032. This, in turn, strengthens Phathom’s market positioning for Voquezna and exponentially enhances the commercial value of the drug. The FDA’s decision to bestow full exclusivity to Voquezna sets a precedent for future drug developments and exclusivity applications within the market. This could potentially fuel further research and development efforts, paving the way for the next wave of innovative therapeutics. The FDA, after reviewing the petition, concurred with Phathom’s interpretation that the 10-year exclusivity granted to the Voquezna Paks should also apply to Voquezna. The agency cited long-established legal and regulatory precedents supporting its decision and pledged to update the Orange Book accordingly. This move is an assertive response to the citizen petition from Phathom, which argued that Voquezna, containing the same active moiety vonoprazan as the Voquezna Triple Pak and Dual Pak, warrants the same new chemical entity plus GAIN Act-based exclusivity period. This development underscores the broader trend of growing regulatory exclusivity in the pharmaceutical industry, and the potential market shifts it can invoke. The FDA’s
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