HALAVEN Drug Patent Profile
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When do Halaven patents expire, and what generic alternatives are available?
Halaven is a drug marketed by Eisai Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-eight patent family members in fourteen countries.
The generic ingredient in HALAVEN is eribulin mesylate. Sixteen 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 on April 5th, 2024.
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Questions you can ask:
- What is the 5 year forecast for HALAVEN?
- What are the global sales for HALAVEN?
- What is Average Wholesale Price for HALAVEN?
Summary for HALAVEN
| International Patents: | 38 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HALAVEN |
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 one US patents and two FDA Regulatory Exclusivities.
| 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 | RE46965*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for HALAVEN
See the table below for patents covering HALAVEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 502932 | ⤷ Start Trial | |
| Australia | 2003284242 | METHODS AND COMPOSITIONS FOR USE IN TREATING CANCER | ⤷ Start Trial |
| Australia | 4573999 | Macrocyclic analogs and methods of their use and preparation | ⤷ Start Trial |
| Australia | 762998 | ⤷ Start Trial | |
| Brazil | 9911326 | Análogos macrocìclicos e métodos para seu uso e preparação | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HALAVEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1087960 | 91854 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: ERIBULIN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (HALAVEN ); AUTHORISATION NUMBER AND DATE: EU/1/11/678/001-002, 17.03.2011 |
| 1087960 | 132011901976051 | Italy | ⤷ Start Trial | PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317 |
| 1087960 | C201100037 | Spain | ⤷ Start Trial | PRODUCT NAME: ERIBULINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/678/001-002; DATE OF AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/678/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20110317 |
| 1087960 | C01087960/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513 |
| 1087960 | 122011100031 | Germany | ⤷ Start Trial | PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE HIERVON, INSBESONDERE ERIBULINMESYLAT; REGISTRATION NO/DATE: 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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