HALAVEN Drug Patent Profile
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When do Halaven patents expire, and when can generic versions of Halaven launch?
Halaven is a drug marketed by Eisai Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-eight patent family members in twenty-six countries.
The generic ingredient in HALAVEN is eribulin mesylate. Six suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Halaven
A generic version of HALAVEN was approved as eribulin mesylate by GLAND PHARMA LTD on April 5th, 2024.
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Summary for HALAVEN
| International Patents: | 78 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 63 |
| Patent Applications: | 7 |
| Drug Prices: | Drug price information for HALAVEN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HALAVEN |
| What excipients (inactive ingredients) are in HALAVEN? | HALAVEN excipients list |
| DailyMed Link: | HALAVEN at DailyMed |
Recent Clinical Trials for HALAVEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | Phase 2 |
| Sun Yat-sen University | Phase 2 |
| Shantou Central Hospital | Phase 2 |
Pharmacology for HALAVEN
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Paragraph IV (Patent) Challenges for HALAVEN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| HALAVEN | Injection | eribulin mesylate | 1 mg/2 mL | 201532 | 1 | 2019-12-20 |
US Patents and Regulatory Information for HALAVEN
HALAVEN is protected by two US patents and two FDA Regulatory Exclusivities.
Patents protecting HALAVEN
Macrocyclic analogs and methods of their use and preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Intermediates for the preparation of analogs of Halichondrin B
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting HALAVEN
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDIES E7389-G000-223 AND E7389-G000-213, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HALAVEN
See the table below for patents covering HALAVEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 2011010 | ⤷ Sign Up | |
| Japan | 2013056923 | INTERMEDIATES FOR PREPARATION OF ANALOGS OF HALICHONDRIN B | ⤷ Sign Up |
| Canada | 2335300 | ANALOGUES MACROCYCLIQUES, LEURS PROCEDES D'UTILISATION ET DEPREPARATION (MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION) | ⤷ Sign Up |
| Portugal | 1087960 | ⤷ Sign Up | |
| Norway | 2011018 | ⤷ Sign Up | |
| European Patent Office | 3587408 | INTERMÉDIAIRES POUR LA PRÉPARATION D'HALICHONDRINE B (INTERMEDIATES FOR THE PREPARATION OF HALICHONDRIN B) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HALAVEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1087960 | SPC/GB11/039 | United Kingdom | ⤷ Sign Up | 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 |
| 1087960 | 1190021-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT; REG:NO:/DATE: EG EU/1/11/678/001-002, 2011-03-17 |
| 1087960 | C300493 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317 |
| 1087960 | 25/2011 | Austria | ⤷ Sign Up | PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317 |
| 1087960 | 1191021-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT EU/1/11/678/001-002, 2011-03-17 EG |
| 1087960 | 132011901976051 | Italy | ⤷ Sign Up | PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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