FDA Orange Book · active-ingredient family
Eribulin mesylate
Eribulin mesylate is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HALAVEN · NDA 201532
1
Brand (NDA)
10
Generics (ANDA)
2
Listed patents
2
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALAVENRLD | EISAI INC | NDA 201532 | AP | Nov 15, 2010 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERIBULIN MESYLATE | NATCO | ANDA 217085 | AP | Jun 01, 2026 | |
| ERIBULIN MESYLATE | XGEN PHARMS | ANDA 219054 | AP | Mar 16, 2026 | |
| ERIBULIN MESYLATE | GLENMARK PHARMS | ANDA 218142 | AP | Aug 05, 2025 | |
| ERIBULIN MESYLATE | DR REDDYS | ANDA 217473 | AP | Jul 03, 2025 | |
| ERIBULIN MESYLATE | SANDOZ | ANDA 214310 | AP | Jun 09, 2025 | |
| ERIBULIN MESYLATE | CHIA TAI TIANQING | ANDA 218743 | AP | Mar 04, 2025 | |
| ERIBULIN MESYLATE | BAXTER HLTHCARE CORP | ANDA 217250 | AP | Oct 01, 2024 | |
| ERIBULIN MESYLATE | LONG GROVE PHARMS | ANDA 214850 | AP | Jul 18, 2024 | |
| ERIBULIN MESYLATE | JIANGXI KVVIT PHARM | ANDA 218281 | AP | Jun 28, 2024 | |
| ERIBULIN MESYLATE | GLAND | ANDA 218047 | AP | Apr 05, 2024 |
Marketing exclusivity (2)
- M-280New use / labeling-change exclusivity (3 years)
Sep 13, 2025
9 mo ago
- PEDPediatric exclusivity (adds 6 months)
Mar 13, 2026
3 mo ago
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE46965 | Jan 08, 2027 | in 7 mo | Product |
| RE46965*PED | Jul 08, 2027 | in 1 yr 1 mo |
Eribulin mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
