ERIBULIN MESYLATE - Generic Drug Details
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What are the generic 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 |
---|---|
Australia New Zealand Gynaecological Oncology Group | Phase 2 |
Merck Sharp & Dohme LLC | 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 |
---|---|---|---|
New Zealand | 508597 | Halichondrin analogs useful as anticancer and antimitotic agents | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
European Patent Office | 2272840 | Intermédiaire pour la preparation d'analogues d'halichondrine (Intermediate compound for the preparation of halichondrin analogs) | ⤷ Try a Trial |
Japan | 5226304 | ⤷ Try a Trial | |
Portugal | 1087960 | ⤷ Try a Trial | |
Hungary | E046436 | ⤷ Try a Trial | |
Israel | 227402 | תוצרי ביניים להכנת הליקונדרין b (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 | C300493 | Netherlands | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317 |
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 | 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 | 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 | 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 | 1191021-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT EU/1/11/678/001-002, 2011-03-17 EG |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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