To Get Full Access :

aBLA Filing Intelligence & Biosimilar Opportunity

Vyvgart

Efgartigimod Alfa-Fcab
Immunomodulators
Injection Injectable

Vyvgart (efgartigimod alfa) targeted the pathogenic IgG autoantibodies driving generalized myasthenia gravis, in a field that had relied on broad immunosuppression, plasma exchange, or IVIG.

By blocking FcRn, it prevents IgG recycling so circulating antibodies, including the pathogenic ones, are cleared faster. Weekly intravenous infusions are given in cycles to adults with generalized myasthenia gravis who test positive for anti-acetylcholine receptor antibodies.

Vyvgart has since added a subcutaneous formulation and expanded into chronic inflammatory demyelinating polyneuropathy, considerably widening its market. With no biosimilar competition, it is the first-in-class benchmark against which the growing FcRn inhibitor class is measured.

Approval Date
17-Dec-21
Data Exclusivity Expiry
17-Dec-25
Market Exclusivity Expiry
17-Dec-33
Commercial snapshot

Market performance & projections

Revenue ($M)
4,179
CAGR (%)
22.89%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
6,025
2027
7,259
2028
8,461
2029
9,531
2030
10,405
2031
11,285
2032
12,293
Molecule profile

Details & specifications

Molecule
Efgartigimod Alfa-Fcab
Innovator
ARGENX US
Dosage Form
Injection Injectable
Strength
400 mg
Therapeutic Category
Immunomodulators
Usage
To treat generalized myasthenia gravis
Good to know

Frequently asked questions

Ready to act on this opportunity?

Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.
Why Spring Bio Solution

Intelligence you can file on

Verified regulatory data
Milestones tracked against primary FDA sources and refreshed continuously.
Analyst-built projections
Seven-year sales outlooks modeled by our pharma intelligence team.
First-to-file focus
Exclusivity windows framed around the decisions generics teams actually make.
Partnership on demand
From API sourcing to dossier support — one request starts the conversation.

Login With

For full access Sign-up / Sign-in using below Methods:

By continuing, you agree to our Terms & Conditions and Privacy Policy. You can review them anytime.

Are you sure want to logout from NCE Grid?