Piflufolastat F-18 injection drugs (Pylarify) from Lantheus (Notice of Intent to sole source)

The National Institutes of Health Clinical Center is issuing a Notice of Intent to sole‑source the procurement of patient‑ready Piflufolastat F‑18 (Pylarify™) radiopharmaceutical doses. The product is FDA‑approved, NRC‑regulated, and must be compounded, calibrated, and delivered on‑demand for prostate‑cancer imaging. Progenics Pharmaceuticals, Inc. (a subsidiary of Lantheus Holdings) is the exclusive authorized vendor under GSA Federal Supply Schedule contract 36F79719D0170. The requirement is structured as an Indefinite Delivery/Indefinite Quantity (IDIQ) with an estimated 150‑230 doses per year plus fees for up to four unused doses. The base period runs 10/01/2026 – 09/30/2027 with four optional one‑year extensions. Interested parties may submit a capability statement by 09/29/2026. • Sole‑source to Progenics Pharmaceuticals, the only FDA‑ and NRC‑certified supplier of Pylarify in the U.S. • Quantity: 150‑230 patient‑ready doses annually (plus up to 4 unused‑dose fees). • Delivery: On‑demand to NIH Nuclear Pharmacy, Bethesda, MD. • Contract period: 12‑month base year with up to four one‑year options (total up to 5 years). • Submission: Capability statements due 09/29/2026 via email to lu‑[email protected].