Phathom Pharmaceuticals Files US FDA Petition to Seek Voquezna Exclusivity Period

MT Newswires Live12-11

Phathom Pharmaceuticals (PHAT) said Wednesday it has filed a Citizen Petition with the US Food and Drug Administration to request a 10-year New Chemical Entity exclusivity period ending May 3, 2032, for Voquezna (vonoprazan) tablets in the Orange Book listings.

The Orange Book is the common name for the organization's Approved Drug Products with Therapeutic Equivalence Evaluations publication, according to the FDA website.

The company said the exclusivity period, granted under the Generating Antibiotic Incentives Now Act for other vonoprazan-based products approved in 2022, should also apply to VOQUEZNA tablets.

The New Chemical Entity protection prohibits generic competition during the exclusivity period and aligns with legal and regulatory precedents, Phathom said.

The company also said it expects the FDA to respond to the petition within 180 days.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment