aBLA Filing Intelligence & Biosimilar Opportunity

Datroway

Datopotamab Deruxtecan-Dlnk

Anticancer

Intravenous Injection

Datroway is an antibody-drug conjugate for adults with advanced non-small cell lung cancer that has an EGFR mutation and progressed after standard treatment. It delivers targeted chemotherapy directly to cancer cells to control tumor growth.

Approval Date

17-Jan-25

Data Exclusivity Expiry

17-Jan-29

Market Exclusivity Expiry

17-Jan-37

Commercial snapshot

Market performance & projections

Revenue ($M)

385

CAGR (%)

0.6039

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

821

2027

1268

2028

1903

2029

2548

2030

3158

2031

3740

2032

4271

Molecule profile

Details & specifications

Molecule

Datopotamab Deruxtecan-Dlnk

Innovator

DAIICHI SANKYO INC

Dosage Form

Intravenous Injection

Strength

100 mg

Therapeutic Category

Anticancer

Usage

To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease

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.