Prescription medicine
Danicopan Brand names: Voydeya
Danicopan (Voydeya) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the danicopan FDA label on DailyMed (effective May 12, 2026, Alexion Pharmaceuticals Inc.); the NDA 218037 record on Drugs@FDA; every danicopan label on DailyMed.
Highlights of the record
FDA label of May 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA VOYDEYA,.
a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B [ see Warnings and Precautions (5.1) ]. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for encapsulated bacteria specifically, Neisseria meningitidis and Streptococcus pneumoniae at least 2 weeks prior to the first dose of VOYDEYA, unless the risks of delaying therapy with VOYDEYA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria. Patients receiving VOYDEYA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. […]
Used for
From the label: indications and usageVOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).
Forms and strengths
- 100 mg
Kit; film-coated tablet.
On the market
- Earliest approval on file
- March 29, 2024 Voydeya, Alexion Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- August 2, 2038 Voydeya tablets; 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
- 273 through July 30, 2026
What is danicopan used for?
From the label: indications and usageVOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). VOYDEYA is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH) ( 1 ). Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab. Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.
FDA pharmacologic class: Complement Factor D Inhibitor.
Source: FDA drug label (Voydeya), Alexion Pharmaceuticals Inc., effective May 12, 2026 (SPL set ab8d1cbd-a28b-4d49-82ab-5c7460719ac7), via openFDA; the full label on DailyMed
What does the patient leaflet for danicopan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VOYDEYA?VOYDEYA is a medicine that affects your immune system. VOYDEYA may lower the ability of your immune system to fight infections. VOYDEYA increases your chance of getting serious infections caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B . These serious infections may quickly become life-threatening and cause death if not recognized and treated early. You must complete or be up to date with the vaccines against Neisseria meningitidis and Streptococcus pneumoniae at least 2 weeks before your first dose of VOYDEYA. If you have not completed your vaccinations and VOYDEYA must be started right away, you should receive the required vaccinations as soon as possible. If you have not been vaccinated at least 2 weeks before your first VOYDEYA dose, and treatment with VOYDEYA must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you. […] Call your healthcare provider or get emergency medical care right away if you have any of these signs and symptoms of a serious infection: fever with or without chills fever and a rash fever with chest pain and cough fever with breathlessness/fast breathing fever with high heart rate headache with nausea or vomiting headache and a fever headache with a stiff neck or stiff back confusion body aches with flu-like symptoms clammy skin eyes sensitive to light Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 1 week after your last VOYDEYA dose. […]
From the patient leaflet: How should I store VOYDEYA?Store VOYDEYA in the original container between 68°F and 77°F (20°C and 25°C). Keep VOYDEYA and all medicines out of the reach of children.
Source: FDA drug label (Voydeya), Alexion Pharmaceuticals Inc., effective May 12, 2026 (SPL set ab8d1cbd-a28b-4d49-82ab-5c7460719ac7), via openFDA; the full label on DailyMed
Is there a generic for danicopan (Voydeya)?
No generic danicopan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Voydeya tablets: the compound patent runs to February 25, 2035, and the last listed entry to August 2, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the danicopan label say about other medicines?
The danicopan label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Eculizumab | warnings and precautions | If discontinuation of VOYDEYA is necessary, continue background treatment with ravulizumab or eculizumab or consider alternative therapy if necessary. |
| Ravulizumab | warnings and precautions | If discontinuation of VOYDEYA is necessary, continue background treatment with ravulizumab or eculizumab or consider alternative therapy if necessary. |
| Rosuvastatin | drug interactions | For rosuvastatin, the dose should not exceed 10 mg once daily ( 7.1 ). |
Source: FDA drug label (Voydeya), Alexion Pharmaceuticals Inc., effective May 12, 2026 (SPL set ab8d1cbd-a28b-4d49-82ab-5c7460719ac7), via openFDA; the full label on DailyMed
What do FAERS reports show for danicopan?
The FDA Adverse Event Reporting System holds 273 reports that list danicopan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18 are coded as a death and 75 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?
- Danicopan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other