Orange Book product · Brand (NDA)

HALAVEN

ERIBULIN MESYLATE

Brand (NDA)NDA 201532TE APRX EISAI INC

Nov 15, 2010

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 15, 2010
15 yr 10 mo ago
Exclusivity ends · M-280
New use / labeling-change exclusivity (3 years)
Sep 13, 2025
9 mo ago
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Mar 13, 2026
3 mo ago
Today
Patent RE46965 expires
Listed drug product patent expiration.
Jan 08, 2027
in 7 mo
Patent RE46965*PED expires
Listed listed patent expiration.
Jul 08, 2027
in 1 yr 1 mo

Active ingredient

ERIBULIN MESYLATE

Strength

1MG/2ML (0.5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Application

NDA 201532

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE46965	Jan 08, 2027	in 7 mo	Product
RE46965*PED	Jul 08, 2027	in 1 yr 1 mo