Prescription medicine
Iptacopan Brand names: Fabhalta
Iptacopan (Fabhalta) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the iptacopan FDA label on DailyMed (effective July 16, 2026, Novartis Pharmaceuticals Corporation); the NDA 218276 record on Drugs@FDA; every iptacopan label on DailyMed.
Highlights of the record
FDA label of July 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA FABHALTA,.
a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, 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 at least 2 weeks prior to the first dose of FABHALTA, unless the risks of delaying therapy with FABHALTA 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 FABHALTA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. […]
Used for
From the label: indications and usageFABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
Forms and strengths
- 200 mg
Capsule.
On the market
- Earliest approval on file
- December 5, 2023 Fabhalta, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- July 15, 2041 Fabhalta capsules; 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
- 730 through July 30, 2026
What is iptacopan used for?
From the label: indications and usageFABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. ( 1.2 ) the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria. […]
FDA pharmacologic class: Complement Factor B Inhibitor.
Source: FDA drug label (FABHALTA), Novartis Pharmaceuticals Corporation, effective July 16, 2026 (SPL set a76b5845-6e21-4d3b-ad07-cd8df1b60bee), via openFDA; the full label on DailyMed
What does the patient leaflet for iptacopan 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 FABHALTA?FABHALTA is a medicine that affects part of your immune system. FABHALTA may lower the ability of your immune system to fight infections. FABHALTA increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. These serious infections may quickly become life-threatening or cause death if not recognized and treated early. You must complete or update your vaccinations against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of FABHALTA. If you have not completed your vaccinations and FABHALTA must be started right away, you should receive the required vaccinations as soon as possible. If you have not been vaccinated and FABHALTA must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you. If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting FABHALTA. Your healthcare provider will decide if you need additional vaccinations. Vaccines do not prevent all infections caused by encapsulated bacteria. Tell your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection: ▪ fever with or without shivers or chills ▪ fever with chest pain and cough ▪ fever with high heart rate ▪ headache and fever ▪ confusion ▪ clammy skin ▪ fever and a rash ▪ fever with breathlessness or fast breathing ▪ headache with nausea or vomiting ▪ headache with stiff neck or stiff back ▪ body aches with flu-like symptoms ▪ eyes sensitive to light Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. […]
From the patient leaflet: How should I store FABHALTA?Store FABHALTA capsules at room temperature between 68°F to 77°F (20°C to 25°C). The FABHALTA container contains a child resistant cap. Keep FABHALTA and all medicines out of the reach of children.
Source: FDA drug label (FABHALTA), Novartis Pharmaceuticals Corporation, effective July 16, 2026 (SPL set a76b5845-6e21-4d3b-ad07-cd8df1b60bee), via openFDA; the full label on DailyMed
Is there a generic for iptacopan (Fabhalta)?
No generic iptacopan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Fabhalta capsules: the compound patent runs to May 25, 2041, and the last listed entry to July 15, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the iptacopan label say about other medicines?
The iptacopan label names 2 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 |
|---|---|---|
| Gemfibrozil | drug interactions | Monitor for loss of efficacy. ( 7.1 ) Strong CYP2C8 inhibitors (e.g., gemfibrozil): May increase iptacopan exposure. |
| Rifampin | drug interactions | DRUG INTERACTIONS CYP2C8 inducers (e.g., rifampin): May decrease iptacopan exposure. |
Source: FDA drug label (FABHALTA), Novartis Pharmaceuticals Corporation, effective July 16, 2026 (SPL set a76b5845-6e21-4d3b-ad07-cd8df1b60bee), via openFDA; the full label on DailyMed
What do FAERS reports show for iptacopan?
The FDA Adverse Event Reporting System holds 730 reports that list iptacopan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 44 are coded as a death and 171 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Iptacopan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other