secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2025-06-06T23:59:59+00:00
Accession:  0001193125-25-137094
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA grants Phathom citizen petition; VOQUEZNA exclusivity extended to May 2032
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- FDA approved Phathom's 2024 citizen petition to correct Orange Book for VOQUEZNA (vonoprazan) tablets.
- VOQUEZNA will benefit from the 10-year NCE*GAIN exclusivity originally awarded to VOQUEZNA Triple Pak and Dual Pak.
- FDA will update Orange Book to reflect exclusivity extending through May 3, 2032 (previously May 3, 2027).
- Decision protects VOQUEZNA from generic competition for an additional 5 years under FDA's umbrella policy.
- VOQUEZNA was not itself designated as a QIDP, but the exclusivity attaches to the active moiety vonoprazan.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312525137094/0001193125-25-137094-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312525137094/d941196d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-137094

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer