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. Seven 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 |
---|---|
Guangdong Provincial People's Hospital | Phase 2 |
First Affiliated Hospital, Sun Yat-Sen University | Phase 2 |
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 | 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 |
---|---|---|---|
Russian Federation | 2245335 | МАКРОЦИКЛИЧЕСКОЕ СОЕДИНЕНИЕ И СПОСОБ ИДЕНТИФИКАЦИИ АГЕНТА НА ЕГО ОСНОВЕ (MACROCYCLIC COMPOUND AND METHOD FOR IDENTIFYING AGENT BASED ON THEREOF) | ⤷ Sign Up |
Japan | 6306235 | ⤷ Sign Up | |
Israel | 180252 | תרכובות ושיטות להכנת אנלוג של@הליקונדרין@b (Compounds and methods for the preparation of an analog of halichondrin b) | ⤷ Sign Up |
Japan | 5964926 | ⤷ Sign Up | |
France | 11C0038 | ⤷ Sign Up | |
China | 108997267 | 用于制备软海绵素B的类似物的中间体 (INTERMEDIATES FOR PREPARATION OF HALICHONDRIN B ANALOGS) | ⤷ 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 | 11C0038 | France | ⤷ Sign Up | PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317 |
1087960 | 91854 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ERIBULIN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (HALAVEN ); AUTHORISATION NUMBER AND DATE: EU/1/11/678/001-002, 17.03.2011 |
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 | CA 2011 00022 | Denmark | ⤷ Sign Up | |
1087960 | 300493 | 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 | 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 |