Eribulin mesylate - Generic Drug Details
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What are the generic drug sources for eribulin mesylate and what is the scope of patent protection?
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 |
Anatomical Therapeutic Chemical (ATC) Classes for eribulin mesylate
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 |
---|---|---|---|
Russian Federation | 2245335 | МАКРОЦИКЛИЧЕСКОЕ СОЕДИНЕНИЕ И СПОСОБ ИДЕНТИФИКАЦИИ АГЕНТА НА ЕГО ОСНОВЕ (MACROCYCLIC COMPOUND AND METHOD FOR IDENTIFYING AGENT BASED ON THEREOF) | ⤷ Try a Trial |
South Korea | 101434673 | ⤷ Try a Trial | |
South Africa | 200007159 | Macrocyclic analogs and methods of their use and preparation. | ⤷ Try a Trial |
China | 101899026 | Intermediates for the preparation of halichondrin B | ⤷ 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 | C01087960/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513 |
1087960 | 11C0038 | France | ⤷ Try a Trial | PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317 |
1087960 | SPC026/2011 | Ireland | ⤷ Try a Trial | SPC026/2011: 20111128, EXPIRES: 20240615 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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