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 Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
10
Listed patents
2
Next patent expiry
Jan 08, 2027
in 3 mo
Brand (NDA) products
Originator applications
- EISAI INCNDA 2015322010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML (0.5MG/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (10)
Abbreviated applications
- ERIBULIN MESYLATENATCOANDA 2170852026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML (0.5MG/ML) SOLUTION INTRAVENOUS Rx AP - ERIBULIN MESYLATEXGEN PHARMSANDA 2190542026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML (0.5MG/ML) SOLUTION INTRAVENOUS Rx AP - ERIBULIN MESYLATEGLENMARK PHARMSANDA 2181422025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML (0.5MG/ML) SOLUTION INTRAVENOUS Rx AP - ERIBULIN MESYLATEDR REDDYSANDA 2174732025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML (0.5MG/ML) SOLUTION INTRAVENOUS Rx AP - ERIBULIN MESYLATESANDOZANDA 2143102025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML (0.5MG/ML) SOLUTION INTRAVENOUS Rx AP - ERIBULIN MESYLATECHIA 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 MESYLATEBAXTER 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 MESYLATELONG 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 MESYLATEJIANGXI 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 MESYLATEGLANDANDA 2180472024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML (0.5MG/ML) SOLUTION INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-280New use / labeling-change exclusivity (3 years)
1 yr 1 mo ago
- PEDPediatric exclusivity (adds 6 months)
7 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| RE46965 | in 3 mo | Product | |
| RE46965*PED | in 9 mo |
Approval history
FDA approval span
First approval
16 yr 2 mo ago
Most recent approval
5 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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