Halaven is a drug owned by Eisai Inc. It is protected by 7 US drug patents filed from 2013 to 2022. Out of these, 2 drug patents are active and 5 have expired. Halaven's patents will be open to challenges from 13 March, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 08, 2027. Details of Halaven's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
USRE46965 (Pediatric) | Intermediates for the preparation of analogs of Halichondrin B |
Jul, 2027
(2 years from now) | Active |
| USRE46965 | Intermediates for the preparation of analogs of Halichondrin B |
Jan, 2027
(2 years from now) | Active |
|
US6214865 (Pediatric) | Macrocyclic analogs and methods of their use and preparation |
Jan, 2024
(10 months ago) |
Expired
|
| US8097648 | Methods and compositions for use in treating cancer |
Jan, 2021
(3 years ago) |
Expired
|
| US6214865 | Macrocyclic analogs and methods of their use and preparation |
Jun, 2019
(5 years ago) |
Expired
|
| US6469182 | Intermediates in the preparation of macrocyclic analogs |
Jun, 2019
(5 years ago) |
Expired
|
| US7470720 | Methods and compositions for use in treating cancer |
Jun, 2019
(5 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Halaven's patents.
Latest Legal Activities on Halaven's Patents
Given below is the list of recent legal activities going on the following patents of Halaven.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 19 Feb, 2024 | US8097648 |
| Maintenance Fee Reminder Mailed Critical | 04 Sep, 2023 | US8097648 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Jun, 2020 | US7470720 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jul, 2019 | US8097648 |
| Post Issue Communication - Certificate of Correction | 28 Jun, 2018 | US7470720 |
| Post Issue Communication - Certificate of Correction | 23 Jan, 2017 | US6469182 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Jan, 2012 | US8097648 |
| Recordation of Patent Grant Mailed Critical | 17 Jan, 2012 | US8097648 |
| Email Notification Critical | 30 Dec, 2011 | US8097648 |
| Issue Notification Mailed Critical | 28 Dec, 2011 | US8097648 |
FDA has granted several exclusivities to Halaven. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Halaven, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Halaven.
Exclusivity Information
Halaven holds 6 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Halaven's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 15, 2015 |
| New Indication(I-721) | Jan 28, 2019 |
| Orphan Drug Exclusivity(ODE) | Jan 28, 2023 |
| Orphan Drug Exclusivity(ODE-107) | Jan 28, 2023 |
| M(M-280) | Sep 13, 2025 |
| Pediatric Exclusivity(PED) | Mar 13, 2026 |
US patents provide insights into the exclusivity only within the United States, but Halaven is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Halaven's family patents as well as insights into ongoing legal events on those patents.
Halaven's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Halaven's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 08, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Halaven Generic API suppliers:
Eribulin Mesylate is the generic name for the brand Halaven. 4 different companies have already filed for the generic of Halaven, with Baxter Hlthcare Corp having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Halaven's generic
How can I launch a generic of Halaven before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Halaven's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Halaven's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Halaven -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/2 mL | 20 Dec, 2019 | 1 | 08 Jan, 2027 |
About Halaven
Halaven is a drug owned by Eisai Inc. It is used for treating patients with metastatic breast cancer. Halaven uses Eribulin Mesylate as an active ingredient. Halaven was launched by Eisai Inc in 2010.
Approval Date:
Halaven was approved by FDA for market use on 15 November, 2010.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Halaven is 15 November, 2010, its NCE-1 date is estimated to be 13 March, 2025.
Active Ingredient:
Halaven uses Eribulin Mesylate as the active ingredient. Check out other Drugs and Companies using Eribulin Mesylate ingredient
Treatment:
Halaven is used for treating patients with metastatic breast cancer.
Dosage:
Halaven is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/2ML (0.5MG/ML) | SOLUTION | Prescription | INTRAVENOUS |