aBLA Filing Intelligence & Biosimilar Opportunity

Imaavy

Nipocalimab-Aahu

Immunomodulators

Injection

Imaavy is an IV antibody for adults and teens aged 12 and older with generalized myasthenia gravis who test positive for AChR or MuSK antibodies. It targets and blocks the FcRn receptor to reduce harmful autoantibodies and improve muscle strength.

Approval Date

29-Apr-25

Data Exclusivity Expiry

29-Apr-29

Market Exclusivity Expiry

29-Apr-37

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

210

2027

600

2028

947

2029

1340

2030

1595

2031

1823

2032

2022

Molecule profile

Details & specifications

Molecule

Nipocalimab-Aahu

Innovator

JANSSEN BIOTECH, INC.

Dosage Form

Injection

Strength

300 mg/1.62 mL and 1200 mg/6.5 mL

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.