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halaven Drug Profile
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Which patents cover Halaven, and what generic alternatives are available?
Halaven is a drug marketed by Eisai Inc and is included in one NDA. There are three patents protecting this drug.
This drug has eighty patent family members in twenty-seven countries.
The generic ingredient in HALAVEN is eribulin mesylate. Two suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.
DrugPatentWatch® Generic Entry Outlook for Halaven
Halaven was eligible for patent challenges on November 15, 2014.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 8, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for halaven
| International Patents: | 80 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 15 |
| Clinical Trials: | 51 |
| Patent Applications: | 7 |
| Drug Prices: | Drug price information for halaven |
| What excipients (inactive ingredients) are in halaven? | halaven excipients list |
| DailyMed Link: | halaven at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for halaven
Generic Entry Date for halaven*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for halaven
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Phase 2 |
| National Cancer Institute (NCI) | Phase 3 |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2 |
Pharmacology for halaven
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Paragraph IV (Patent) Challenges for HALAVEN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HALAVEN | SOLUTION;INTRAVENOUS | eribulin mesylate | 201532 | 2019-12-20 |
US Patents and Regulatory Information for halaven
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for halaven
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | Start Trial | Start Trial |
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | Start Trial | Start Trial |
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for halaven
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 109180615 | Start Trial |
| European Patent Office | 2277873 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2004034990 | Start Trial |
| Norway | 2011018 | Start Trial |
| Denmark | 1087960 | Start Trial |
| Israel | 267606 | Start Trial |
| Norway | 2011026 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for halaven
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1087960 | 25/2011 | Austria | Start Trial | PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317 |
| 1087960 | 2011C/028 | Belgium | Start Trial | PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 20110317 |
| 1087960 | C300493 | Netherlands | Start Trial | PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317 |
| 1087960 | C01087960/01 | Switzerland | Start Trial | PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513 |
| 1087960 | 11C0038 | France | Start Trial | PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317 |
| 1087960 | 1190021-4 | Sweden | Start Trial | PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT; REG. NO/DATE: EU/1/11/678/001-002 20110317 |
| 1087960 | SPC/GB11/039 | United Kingdom | Start Trial | PRODUCT NAME: ERIBULIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/11/678/001 20110317; UK EU/1/11/678/002 20110317 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
