Prescription medicine
Fosdenopterin Brand names: Nulibry
Fosdenopterin (Nulibry) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the fosdenopterin FDA label on DailyMed (effective May 26, 2026, Sentynl Therapeutics, Inc.); the NDA 214018 record on Drugs@FDA; every fosdenopterin label on DailyMed.
Highlights of the record
FDA label of May 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A.
Forms and strengths
- 9.5 mg
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- February 26, 2021 Nulibry, Sentynl Theraps Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 9, 2029 Nulibry injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4 through July 30, 2026
What is fosdenopterin used for?
From the label: indications and usageNULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. NULIBRY is cyclic pyranopterin monophosphate (cPMP) indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A.
FDA pharmacologic class: Cyclic Pyranopterin Monophosphate.
Source: FDA drug label (Nulibry), Sentynl Therapeutics, Inc., effective May 26, 2026 (SPL set 736aeea3-f206-454d-95d0-fd30964e8aab), via openFDA; the full label on DailyMed
What does the patient leaflet for fosdenopterin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid during treatment with NULIBRY?NULIBRY may cause skin reactions. Limit or avoid your child's exposure or time in sunlight and artificial ultraviolet (UV) light, such as UVA or UVB phototherapy. Your child should wear clothing, a hat, and sunglasses that protect against sun exposure. If your child is 6 months of age or older apply a broad spectrum sunscreen with high sun protection factor. Get medical help right away if your child develops a rash, or if you notice symptoms of a skin reaction, including: skin redness, blisters, or if your child feels like their skin is burning.
From the patient leaflet: How should I store NULIBRY?Frozen vials: Store NULIBRY in the freezer between −13°F to 14°F (−25°C to −10°C). Keep NULIBRY vials in the original carton to protect from light until you are ready to use it. Vials of NULIBRY after mixing: Store vials of NULIBRY that have been mixed at room temperature 59°F to 77°F (15°C to 25°C) or in the refrigerator at 36°F to 46 °F (2°C to 8°C), until you are ready to give the dose. Vials of NULIBRY are for 1 time use only. Throw the vial away after use, even if there is medicine left in the vial. Do not save for later use. Used vials may be thrown away in your household trash. Preparing to give NULIBRY Step 1: Gather Supplies Use a clean, flat work surface. Remove from the freezer the NULIBRY vials needed to prepare your child's prescribed dose. You may need more than 1 vial to prepare the total amount needed for 1 dose. Allow the NULIBRY vials to reach room temperature. […]
Source: FDA drug label (Nulibry), Sentynl Therapeutics, Inc., effective May 26, 2026 (SPL set 736aeea3-f206-454d-95d0-fd30964e8aab), via openFDA; the full label on DailyMed
Is there a generic for fosdenopterin (Nulibry)?
No generic fosdenopterin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Nulibry injection, the last expiring on April 9, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for fosdenopterin?
The FDA Adverse Event Reporting System holds 4 reports that list fosdenopterin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 2 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Fosdenopterin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other