aBLA Filing Intelligence & Biosimilar Opportunity

Beyfortus

Nirsevimab-Alip

Antiviral

Intramuscular Injection

Beyfortus is a single-dose antibody given to newborns and infants to prevent serious RSV (respiratory syncytial virus) lung infections during their first two RSV seasons. It reduces hospitalizations by about 70 to 80%.

Approval Date

17-Jul-23

Data Exclusivity Expiry

17-Jul-27

Market Exclusivity Expiry

17-Jul-35

Commercial snapshot

Market performance & projections

Revenue ($M)

2656

CAGR (%)

0.048

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

2684

2027

2915

2028

3096

2029

3204

2030

3308

2031

3413

2032

3510

Molecule profile

Details & specifications

Molecule

Nirsevimab-Alip

Innovator

SANOFI

Dosage Form

Intramuscular Injection

Strength

100 mg/1 mL and 50 mg/0.5 mL

Therapeutic Category

Antiviral

Usage

To prevent respiratory syncytial virus (RSV) lower respiratory tract disease

Good to know

Frequently asked questions

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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.

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