Eribulin mesylate - Generic Drug Details
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What are the generic drug sources for eribulin mesylate and what is the scope of freedom to operate?
Eribulin mesylate
is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Eribulin mesylate has seventy-eight patent family members in twenty-six countries.
Two suppliers are listed for this compound.
Summary for eribulin mesylate
| International Patents: | 78 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 84 |
| Patent Applications: | 9 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for eribulin mesylate |
| What excipients (inactive ingredients) are in eribulin mesylate? | eribulin mesylate excipients list |
| DailyMed Link: | eribulin mesylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for eribulin mesylate
Generic Entry Date for eribulin mesylate*:
Constraining patent/regulatory exclusivity:
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 eribulin mesylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme LLC | Phase 2 |
| Australia New Zealand Gynaecological Oncology Group | Phase 2 |
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
Pharmacology for eribulin mesylate
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Paragraph IV (Patent) Challenges for ERIBULIN MESYLATE
| 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 eribulin mesylate
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 eribulin mesylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for eribulin mesylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 762998 | ⤷ Try a Trial | |
| Portugal | 1087960 | ⤷ Try a Trial | |
| China | 1216051 | ⤷ Try a Trial | |
| Japan | 2016183171 | ハリコンドリンＢ類似体の調製用中間体 (INTERMEDIATES FOR PREPARATION OF HALICHONDRIN B ANALOGS) | ⤷ Try a Trial |
| Croatia | P20150543 | ⤷ Try a Trial | |
| Norway | 331183 | ⤷ Try a Trial | |
| Israel | 139960 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for eribulin mesylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1087960 | CA 2011 00022 | Denmark | ⤷ Try a Trial | |
| 1087960 | 1190021-4 | Sweden | ⤷ Try a Trial | 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 | C201100037 | Spain | ⤷ Try a 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 | 91854 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ERIBULIN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (HALAVEN ); AUTHORISATION NUMBER AND DATE: EU/1/11/678/001-002, 17.03.2011 |
| 1087960 | 122011100031 | Germany | ⤷ Try a Trial | PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE HIERVON, INSBESONDERE ERIBULINMESYLAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317 |
| 1087960 | C01087960/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513 |
| 1087960 | SPC/GB11/039 | United Kingdom | ⤷ Try a 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 |
Make Better Decisions: Try a trial or see plans & pricing
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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