This Presolicitation opportunity from Department Of Health And Human Services was posted on September 22, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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

Closed

NOI-27-000004Federal

Submission Closed09/29/2026, 10:00:00 AM EDT

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 325412

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1 day ago

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in 4 days

AI Contract Overview

The National Institutes of Health Clinical Center intends to award a sole-source contract to Progenics Pharmaceuticals Inc., a Lantheus company, for the procurement of Piflufolastat F-18 injection (Pylarify). This FDA-approved radiopharmaceutical is used for the scintigraphic localization of prostate-specific membrane antigen positive lesions in men with prostate cancer. Due to the rapid radiation decay and short half-lives of the drug, it must be compounded, calibrated, and delivered as patient-ready unit doses on demand to the NIH Clinical Center Nuclear Pharmacy Facility in Bethesda, Maryland. The procurement is justified under FAR 8.405-6(b) and 41 U.S.C. 1901(a)(1) because Progenics Pharmaceuticals is the sole authorized provider and intellectual property owner capable of meeting the highly specialized quality and regulatory requirements of the FDA and the U.S. Nuclear Regulatory Commission. The contract is structured as an Indefinite Delivery/Indefinite Quantity requirement for 150 to 230 injections and four unused dose fees. The period of performance consists of a base year from October 1, 2026, to September 30, 2027, with four subsequent option years extending through September 30, 2031. The award will be made using GSA Contract 36F79719D0170 and includes an economic price adjustment clause per FAR 52.216-2 for 2026 pricing. Performance is measured by the accuracy of delivered doses, the absence of contamination, and strict adherence to federal regulatory standards.

General Info

NIH sole-source contract with Progenics Pharmaceuticals for Pylarify injections through September 2031.

Agency

Department Of Health And Human Services → National Institutes Of Health - Cc

NAICS

325412 - Pharmaceutical Preparation Manufacturing

Place of Performance

Bethesda, MD, 20814, USA

Set-Aside

NONE

Documents

sow

High

justification-and-authorization

Low

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseClosed

PostedSep 22

Presolicitation

Response DeadlineSep 29

Deadline has passed

Submission Closed

09/29/2026, 10:00:00 AM EDT

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

Contacts1 person available

OfficeBETHESDA, MD, 20892, USA

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

Office AddressBETHESDA, MD, 20892, USA

Contacts

Lu Chang

contact@example.gov

Full Description

Acquisition Description:

This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Progenics Pharmaceuticals Inc.

The National Institute of Health, Clinical Center (NIH-CC)’s has the Nuclear Pharmacy (CC NP) department (collectively “Program”) that purchases and compounds radiopharmaceuticals (radioactive drugs) on a daily basis for life-saving clinical nuclear medicine procedures. This is essential for the NIH Clinical Center to achieve optimal patient care. These radiopharmaceuticals are United States Food and Drug Administration (FDA) approved drugs for use in patients. They are also radioactive materials that are regulated by the United States Nuclear Regulatory Commission (US NRC) through the NIH radioactive material license (RAM) administered by the NIH Radiation Safety Office (RSO). Only RSO certified Nuclear Medicine personnel can order these radiopharmaceuticals directly for patient use. Each radiopharmaceutical is time sensitive because of the rapid radiation decay. Because of their short useful half-lives, they cannot be ordered in advance for storage. They must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date on a daily basis.

The purpose is to procure compounded piflufolasta F-18 in patient ready unit doses (UDs) from an authorized nuclear pharmacy for the use by the NIH Nuclear Medicine, Department of Radiology and Imaging Sciences to diagnose and treat diseases as required by necessary patient care protocols at the NIH Clinical Center. This new radioactive drug is vital to the NIH Clinical Center mission.

The product is owned and developed by Lantheus Medical/Progenics Pharmaceuticals (now merged as one company). Progenics Pharmaceuticals Inc uses Lantheus’ Federal Supply Schedule contract on contract 36F79719D0170.

Justification and other information:

This requirement will be sole sourced to Progenics Pharmaceuticals Inc. under FAR 8.405-6 (b): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. This notice is being made on SAM.gov instead of GSA Ebuy because the GSA Ebuy category “65 I B PHARMACEUTICALS AND DRUGS” states that “This SIN is not available through GSA Advantage.”

Lantheus Medical Imaging (a company of Lanntheus Holding, Inc.) is the developer and intellectual property owner of Piflufolastat F-18 injection drugs (Pylarify) in the United States. More specifically, Progenics Pharmceuticals had been developing this drug and Lantheus merged Progenics Pharmaceuticals. Progenics Pharmaceuticals Inc is the only local authorized commercial nuclear pharmacy authorized by Lanthesus Medical Imaging to compound, prepare, delivery and invoice for these drugs. They use the Federal Supply Schedule contract on contract 36F79719D0170, and they are the designated authorized vendor for our area.

Only this drug can be used for Program’s patient care and research and Program has been using these drugs for years in ongoing projects and patient care. Only qualified vendors that meet the FDA and US NRC regulations can provide these radiopharmaceuticals for compounding and dispensing at NIH Nuclear Pharmacy to NIH Clinical Center patients. Thus, only Progenics Pharmaceuticals Inc. is the sole authorized provider of these drugs.

Indefinite Delivery/Indefinite Quantity (IDIQ) Requirement:

150x to 230x Qty of PYLARIFY piflufolastat F-18 injections

4x Qty for PYLARIFY unused doses fees

Base Year

Option Year 1

Option Year 2

Option Year 3

Option Year 4

Place of Performance or Delivery:

The contract period of performance is 10/01/2026 – 09/30/2027 for the base year.

Option Years:

10/01/2027 – 09/30/2028

10/01/2028 – 09/30/2029

10/01/2029 – 09/30/2030

10/01/2030 – 09/30/2031

This requirement will be awarded on GSA Contract #36F79719D0170.

Place of Performance: NIH Clinical Center in Bethesda, MD

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 and/or FAR 8.405-6 - only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-000004) by 10:00 AM eastern standard time on 09/29/2026 to: contact@example.gov

All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.