Is there a generic for Eribulin mesylate?

Yes. The FDA Orange Book lists 10 approved generic (ANDA) applications for Eribulin mesylate, referencing the brand HALAVEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Eribulin mesylate?

HALAVEN (NDA 201532, EISAI INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Eribulin mesylate?

The Orange Book lists 2 patents against Eribulin mesylate products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Eribulin mesylate have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Eribulin mesylate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Eribulin mesylate are approved?

Eribulin mesylate is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Eribulin mesylate

Eribulin mesylate: 1 brand, 10 generics; first approved Nov 15, 2010; generic available.

Generic available2 exclusivity periods

Generic status & protection

Generic available — 10 ANDA applications approved.

Earliest patent expiry Jan 08, 2027Latest exclusivity ends Mar 13, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 08, 2027

in 6 mo

Originator applications

Brand (NDA) products

HALAVENRLDRS

EISAI INCNDA 2015322010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Abbreviated applications

Generic (ANDA) products (10)

ERIBULIN MESYLATE

NATCOANDA 2170852026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

XGEN PHARMSANDA 2190542026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

GLENMARK PHARMSANDA 2181422025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

DR REDDYSANDA 2174732025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

SANDOZANDA 2143102025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

CHIA TAI TIANQINGANDA 2187432025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

BAXTER HLTHCARE CORPANDA 2172502024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

LONG GROVE PHARMSANDA 2148502024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

JIANGXI KVVIT PHARMANDA 2182812024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

ERIBULIN MESYLATE

GLANDANDA 2180472024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/2ML (0.5MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

M-280New use / labeling-change exclusivity (3 years)
Sep 13, 2025
10 mo ago
PEDPediatric exclusivity (adds 6 months)
Mar 13, 2026
4 mo ago

Orange Book patent file

Listed patents

Listed patents (2)

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 6 mo	Product
RE46965*PED	Jul 08, 2027	in 1 yr

FDA approval span

Approval history

First approval

Nov 15, 2010

15 yr 11 mo ago

Most recent approval

Jun 01, 2026

1 mo ago

Approvals span 2010–2026 across 11 FDA applications.

Brand (NDA) 19%

Generic (ANDA) 1091%

Eribulin mesylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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