Ecallantide bulk supplier for pharma manufacturers

Ecallantide 10 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 10 mg/mL

Reference Brands: Kalbitor(USA/EU)

Ecallantide is a recombinant plasma kallikrein inhibitor used to treat acute hereditary angioedema (HAE) attacks. It works by blocking kallikrein activity, reducing the production of bradykinin, and thereby preventing or decreasing swelling.

Ask About Access

Usually answered within 48 hours | GMP documents shared before you commit

Manufacture or export Ecallantide? List it or send an offer →

Product Description:

Ecallantide is a recombinant protein, developed by phage display, that inhibits plasma kallikrein. In hereditary angioedema, deficient or dysfunctional C1 esterase inhibitor allows kallikrein to run unchecked, cleaving high molecular weight kininogen to release bradykinin, which makes blood vessels leak and produces the swelling attacks. Blocking kallikrein stops bradykinin generation and halts an attack in progress.

It is used for acute attacks in patients aged twelve and over, given as three subcutaneous injections at one time. Its defining constraint is a boxed warning for anaphylaxis, which occurs in a small but significant proportion of patients and can mimic the attack it is being given to treat. For that reason it must be administered by a healthcare professional with the means to manage anaphylaxis, which rules out the self-administration that patients with laryngeal attacks need. That, more than efficacy, is why newer on-demand options have displaced it.

Sourcing notes. A US product; the European marketing authorisation application was withdrawn by the sponsor, so it is not an EU product. Cold chain. Because administration must be supervised, the buyers are hospitals and infusion centres rather than specialty pharmacy, which is a different distribution route from most HAE products.

How Ecallantide is supplied today, and licensing ahead of patent expiry

Ecallantide is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Ecallantide, hold a dossier for it or want to license it, talk to us.

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

Ask about Ecallantide supply →

Back to Listing

Frequently Asked Questions

Ecallantide is used for the treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years and older. It works by inhibiting plasma kallikrein, which reduces the production of bradykinin and alleviates swelling.

It is made from a recombinant protein that acts as a potent and selective plasma kallikrein inhibitor.

The trade name is Kalbitor.

Kalbitor is manufactured by Dyax Corp, a subsidiary of Shire Pharmaceuticals.

The generic name is Ecallantide.

The brand name is Kalbitor.

It is manufactured in approved biologics production facilities in the United States for commercial distribution.

Kalbitor (Ecallantide) is developed and sold by Takeda. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.