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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Eribulin mesylate has eighty patent family members in twenty-seven countries.
Two suppliers are listed for this compound.
Summary for eribulin mesylate
| International Patents: | 80 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 26 |
| Clinical Trials: | 71 |
| Patent Applications: | 7 |
| DailyMed Link: | eribulin mesylate at DailyMed |
Recent Clinical Trials for eribulin mesylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Phase 2 |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2 |
| Immunomedics, Inc. | Phase 3 |
Pharmacology for eribulin mesylate
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Paragraph IV (Patent) Challenges for ERIBULIN MESYLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HALAVEN | SOLUTION;INTRAVENOUS | eribulin mesylate | 201532 | 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 | 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 | |||
| 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 | ||||
| >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 | 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 eribulin mesylate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1087960 | Start Trial |
| Japan | 2002518384 | Start Trial |
| European Patent Office | 2272840 | Start Trial |
| European Patent Office | 2277873 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for eribulin mesylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1087960 | 132011901976051 | Italy | Start Trial | PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317 |
| 1087960 | 91854 | Luxembourg | Start Trial | 91854, EXPIRES: 20240616 |
| 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 | 25/2011 | Austria | Start Trial | PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; 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. 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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