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 two branded drugs marketed by Gland Pharma Ltd and Eisai Inc, and is included in two NDAs. 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.
Four suppliers are listed for this compound.
Summary for eribulin mesylate
International Patents: | 78 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 84 |
Patent Applications: | 8 |
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 |
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 |
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 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eisai Inc | HALAVEN | eribulin mesylate | SOLUTION;INTRAVENOUS | 201532-001 | Nov 15, 2010 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
---|---|---|---|
Japan | 4454151 | ⤷ Try a Trial | |
Canada | 2335300 | ANALOGUES MACROCYCLIQUES, LEURS PROCEDES D'UTILISATION ET DEPREPARATION (MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION) | ⤷ Try a Trial |
Australia | 762998 | ⤷ Try a Trial | |
Canada | 2632433 | ANALOGUES MACROCYCLIQUES, LEURS PROCEDES D'UTILISATION ET DEPREPARATION (MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION) | ⤷ 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 | 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 |
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 | 2011C/028 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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