FDA Orange Book
Generic for Halaven
Halaven contains eribulin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Halaven is eribulin. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Halaven and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Halaven products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 1MG/2ML (0.5MG/ML) | Marketed (Rx) | AP | 10 | AP |
NDA 201532, held by EISAI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic eribulin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLAND PHARMA LTD | 218047 | AP (A-rated, therapeutically equivalent) | April 5, 2024 | 1MG/2ML (0.5MG/ML) |
| JIANGXI KVVIT PHARMACEUTICAL CO LTD | 218281 | AP (A-rated, therapeutically equivalent) | June 28, 2024 | 1MG/2ML (0.5MG/ML) |
| LONG GROVE PHARMACEUTICALS LLC | 214850 | AP (A-rated, therapeutically equivalent) | July 18, 2024 | 1MG/2ML (0.5MG/ML) |
| BAXTER HEALTHCARE CORP | 217250 | AP (A-rated, therapeutically equivalent) | October 1, 2024 | 1MG/2ML (0.5MG/ML) |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO LTD | 218743 | AP (A-rated, therapeutically equivalent) | March 4, 2025 | 1MG/2ML (0.5MG/ML) |
| SANDOZ INC | 214310 | AP (A-rated, therapeutically equivalent) | June 9, 2025 | 1MG/2ML (0.5MG/ML) |
| DR REDDYS LABORATORIES LTD | 217473 | AP (A-rated, therapeutically equivalent) | July 3, 2025 | 1MG/2ML (0.5MG/ML) |
| GLENMARK PHARMACEUTICALS INC USA | 218142 | AP (A-rated, therapeutically equivalent) | August 5, 2025 | 1MG/2ML (0.5MG/ML) |
| XGEN PHARMACEUTICALS DJB INC | 219054 | AP (A-rated, therapeutically equivalent) | March 16, 2026 | 1MG/2ML (0.5MG/ML) |
| NATCO PHARMA LTD | 217085 | AP (A-rated, therapeutically equivalent) | June 1, 2026 | 1MG/2ML (0.5MG/ML) |
Halaven patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE46965 | January 8, 2027 | Drug product | None | 201532 |
| RE46965*PED | July 8, 2027 | Method of use | None | 201532 |
Halaven exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-280 | Miscellaneous | September 13, 2025 | 201532 |
| PED | Pediatric exclusivity | March 13, 2026 | 201532 |
Halaven NDC codes
Questions
Is there a generic for Halaven?
Yes. The generic name for Halaven is eribulin. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Halaven?
The active ingredient in Halaven is eribulin, per the FDA Orange Book.
When does the Halaven patent expire?
The last patent listed for Halaven in the Orange Book expires July 8, 2027. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.