Phathom Pharmaceuticals, Inc. has received a positive response from the U.S. Food and Drug Administration (FDA) regarding the company's petition related to the exclusivity status of its drug, Voquezna. The FDA has granted the petition, which requested a correction to the publication "Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book)" to accurately reflect the 10-year period of non-patent new chemical entity (NCE) exclusivity for Voquezna.
The exclusivity status of Voquezna is significant as it impacts market competition and the protection of the drug from generic competition. The FDA's decision is based on the statutory interpretation of the 5-year exclusivity provisions, which provide incentives for pharmaceutical innovation and protection for qualified drugs from competition.
Specifically, the FDA's decision grants 10 years of NCE*GAIN exclusivity to Voquezna, aligning with the exclusivity granted to Voquezna Triple Pak and Voquezna Dual Pak. Vonoprazan, the active moiety in Voquezna, was recognized as an NCE upon approval, and the drug received qualified infectious disease product (QIDP) designation, leading to the extension of NCE exclusivity by 5 years.
The FDA's umbrella policy, which allows subsequently approved drug products containing the same active moiety to benefit from the original drug product's exclusivity, has played a crucial role in the decision regarding Voquezna's exclusivity status. This broader interpretation of the coverage of exclusivity aims to encourage further development and improvement of drug products containing the NCE without compromising the innovator's exclusivity period.
The market has reacted to these announcements by moving the company's shares 90.19% to a price of $8.92. Check out the company's full 8-K submission here.
