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Icatibant Acetate Injection shortage

Icatibant Acetate Injection is currently listed in shortage by the FDA. The FDA lists 2 affected products. This page was last refreshed from FDA data on Sep 22, 2026.

To Be Discontinued ⚠ Supply risk: High Hematology 2 products 138 days First posted May 7, 2026 Updated May 7, 2026
Here’s the bottom line

Fresenius Kabi is permanently stopping its icatibant acetate injection 10 mg/1 mL. Other makers — including Takeda, which sells the brand Firazyr (icatibant acetate) — have not reported a shortage, so the medicine is still listed as available from other sources.

Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
2
Affected NDCs
1
Reporting manufacturers
0/1
Reporting mfrs supplying
0/1
Affected strengths supplied
138
Days in shortage
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Sep 22, 2026 · today

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Icatibant Acetate Injection. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
2 NDCs
To be discontinued 2
Affected strengths still supplied
Among manufacturers reporting this shortage
0/1 strengths
No supply 1
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
0/1 makers
No supply 1
✓ Other manufacturers not reporting a shortage
Still-marketed Icatibant Acetate Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Teva Pharmaceuticals USA, Inc. Hikma Pharmaceuticals USA Inc. Takeda Pharmaceuticals America, Inc. Eugia US LLC Alembic Pharmaceuticals Inc. Cipla USA Inc. Cycle Pharmaceuticals Ltd-Uk
See all other options & details →
Shortage timeline
  1. May 7, 2026
    Currently in shortage
    2 of 2 products affected.
  2. May 7, 2026
    First reported to the FDA
    2 products first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Fresenius Kabi USA, LLC 📞 847-550-2300 2 NDCS click to expand
Status NDC / product Strength Availability Related information Reason
To Be Discontinued Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-93) NDC 63323-0574-93 Discontinuation of the manufacturer of the drug
To Be Discontinued Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-86) NDC 63323-0574-86 Discontinuation of the manufacturer of the drug

These rows are manufacturer reports to the FDA for Icatibant Acetate Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Icatibant Acetate Injection? options further down this page.

Why is Icatibant Acetate Injection in shortage?

Fresenius Kabi USA has reported that it is permanently stopping production of its icatibant acetate injection 10 mg/1 mL — both package versions it makes (NDC 63323-574-86 and NDC 63323-574-93) are being discontinued. The reason given is that the manufacturer itself is discontinuing production of this drug.

It's worth knowing that this report only reflects what Fresenius Kabi has filed with the FDA. No specific reason beyond the manufacturer's decision to stop making it was shared publicly, so I can't tell you more about the "why" behind that choice. Other manufacturers of icatibant may be listed separately on the FDA shortage page.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Icatibant Acetate Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Icatibant Acetate Injection?

Icatibant Acetate Injection is currently on the FDA drug-shortage list, and I want to walk you through what that means for you.

The only strength covered by this report is the 10 mg/1 mL injection, and it does not have an available source right now. The reason listed is that the manufacturer who filed this report, Fresenius Kabi USA, is discontinuing this product. Because this is a discontinuation rather than a temporary delay, this supply problem may be permanent for that maker, and no estimated-recovery date is given.

Even so, this report reflects only one manufacturer. The same medicine, icatibant acetate, is still on the market from other companies, so it is not gone everywhere. Here is what I suggest:

  • Do not stop, skip, or change how you use this medicine on your own.
  • Ask your pharmacy to check wholesalers and other manufacturers — the same medicine is available from makers such as Teva, Hikma, Takeda (Firazyr), Eugia, Alembic, Cipla, and Cycle (Sajazir), though these may not be in local stock.
  • Because your current product is being discontinued, talk with your prescriber or pharmacist about a suitable alternative.

Manufacturer contact numbers are listed on this page for reference; your pharmacy usually handles those calls. This is general, national information and may not match your local pharmacy's stock.

See “Where else can I get Icatibant Acetate Injection?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.

Where else can I get Icatibant Acetate Injection?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Icatibant Acetate Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Icatibant ICATIBANT ACETATE 10 mg/mL Injection, Solution · Subcutaneous Teva Pharmaceuticals USA, Inc. 00093-3066-34
Icatibant ICATIBANT ACETATE 30 mg/3mL Injection, Solution · Subcutaneous Hikma Pharmaceuticals USA Inc. 24201-0207-01
Firazyr ICATIBANT ACETATE 30 mg/3mL Injection, Solution · Subcutaneous Takeda Pharmaceuticals America, Inc. 54092-0702-01
Icatibant ICATIBANT ACETATE 30 mg/3mL Injection, Solution · Subcutaneous Eugia US LLC 55150-0351-01
Icatibant ICATIBANT ACETATE 30 mg/3mL Injection · Subcutaneous Alembic Pharmaceuticals Inc. 62332-0654-03
Icatibant ICATIBANT ACETATE 30 mg/3mL Injection · Subcutaneous Cipla USA Inc. 69097-0664-34
Sajazir ICATIBANT ACETATE 30 mg/3mL Injection · Subcutaneous Cycle Pharmaceuticals Ltd-Uk 70709-0013-01
Therapeutic equivalents & pricing 10 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Icatibant 10 mg/mLNDC 00093-3066-34 Teva 1 syringe AP FDA listed
Icatibant 30 mg/3mLNDC 24201-0207-01 Hikma 1 syringe AP FDA listed
Icatibant 30 mg/3mLNDC 46708-0654-03 Alembic 1 syringe AP FDA listed
Firazyr 30 mg/3mLNDC 54092-0702-01 Takeda 1 syringe AP FDA listed
Icatibant 30 mg/3mLNDC 55150-0351-01 Eugia 1 syringe AP FDA listed
Icatibant 30 mg/3mLNDC 62332-0654-03 Alembic 1 syringe AP FDA listed
Icatibant 10 mg/mLNDC 63323-0574-93 Fresenius 1 syringe AP FDA listed
Icatibant 30 mg/3mLNDC 69097-0664-34 Cipla 1 syringe AP FDA listed
Sajazir 30 mg/3mLNDC 70709-0013-01 Cycle 1 syringe AP FDA listed
Icatibant 10 mg/mLNDC 63323-0574-86 Fresenius 1 syringe AP FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Identity & classification

GCN Seq No 064564
GCN 14778
HICL code 035962
Ingredient (HICL) Icatibant Acetate
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A7
Therapeutic class — intermediate (HIC2) Vasoactive Drugs
HIC3 code A7M
Therapeutic class — specific (HIC3) Bradykinin B2 Receptor Antagonists
AHFS code 24:48.04.00
AHFS class Bradykinin Receptors Antagonists
FDB label name ICATIBANT 30 MG/3 ML SYRINGE
FDB brand name Icatibant
Legend status F — Federal legend — prescription drug or device
GPI-148582004010E520
GPI classIcatibant Acetate
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other hematology shortages

Icatibant Acetate Injection shortage FAQs

Is Icatibant Acetate Injection in shortage?
Yes — the FDA currently lists Icatibant Acetate Injection in shortage (status: “To Be Discontinued”, first reported May 7, 2026). 2 of 2 products are affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-93) (NDC 63323-0574-93); Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-86) (NDC 63323-0574-86). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Icatibant Acetate Injection be available again?
The FDA does not publish a guaranteed restock date, and no estimated-recovery note is on file. Availability can change daily — confirm with your pharmacy.
Can I still get Icatibant Acetate somewhere?
Other manufacturers (Teva Pharmaceuticals USA, Inc., Hikma Pharmaceuticals USA Inc., Takeda Pharmaceuticals America, Inc. and others) still market it and have not reported a shortage. See “Where else can I get Icatibant Acetate Injection?” above — stock still varies by pharmacy.
What should I do if I take Icatibant Acetate Injection?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

Still have a question about the Icatibant Acetate Injection shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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