ERIBULIN MESYLATE Drug Patent Profile
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When do Eribulin Mesylate patents expire, and what generic alternatives are available?
Eribulin Mesylate is a drug marketed by Gland Pharma Ltd and is included in one NDA.
The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. Four suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Eribulin Mesylate
A generic version of ERIBULIN MESYLATE was approved as eribulin mesylate by GLAND PHARMA LTD on April 5th, 2024.
Summary for ERIBULIN MESYLATE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 84 |
Patent Applications: | 7 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ERIBULIN MESYLATE |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gland Pharma Ltd | ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 218047-001 | Apr 5, 2024 | AP | RX | No | No | ⤷ 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 |