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: | 43 |
Clinical Trials: | 83 |
Patent Applications: | 11 |
What excipients (inactive ingredients) are in eribulin mesylate? | eribulin mesylate excipients list |
DailyMed Link: | eribulin mesylate at DailyMed |
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | See Plans and Pricing | See Plans and Pricing |
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for eribulin mesylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 122011100031 | See Plans and Pricing | |
European Patent Office | 3587408 | INTERMÉDIAIRES POUR LA PRÉPARATION D'HALICHONDRINE B (INTERMEDIATES FOR THE PREPARATION OF HALICHONDRIN B) | See Plans and Pricing |
Israel | 180252 | תרכובות ושיטות להכנת אנלוג של@הליקונדרין@b (Compounds and methods for the preparation of an analog of halichondrin b) | See Plans and Pricing |
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) | See Plans and Pricing |
European Patent Office | 2272839 | Intermédiaires pour la préparation d'analogues d'halichondrine (Intermediate compounds for the preparation of halichondrin analogs) | See Plans and Pricing |
Canada | 2755266 | METHODES DE PREPARATION D'ANALOGUES MACROCYCLIQUES ET INTERMEDIAIRES POUR CETTE METHODE (METHODS FOR PREPARING MACROCYCLIC ANALOGS AND INTERMEDIATES FOR PREPARING SAME) | See Plans and Pricing |
Hong Kong | 1035534 | MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for eribulin mesylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1087960 | 300493 | Netherlands | See Plans and Pricing | PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317 |
1087960 | CA 2011 00022 | Denmark | See Plans and Pricing | |
1087960 | C201100037 | Spain | See Plans and Pricing | 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 | C300493 | Netherlands | See Plans and Pricing | PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317 |
1087960 | 394 | Finland | See Plans and Pricing | |
1087960 | C01087960/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513 |
1087960 | SPC026/2011 | Ireland | See Plans and Pricing | SPC026/2011: 20111128, EXPIRES: 20240615 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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