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 Baxter Hlthcare Corp, Gland Pharma Ltd, Jiangxi Qingfeng, and Long Grove Pharms. and is included in four NDAs.
The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. Six 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.
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Questions you can ask:
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Summary for ERIBULIN MESYLATE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 4 |
| 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 217250-001 | Oct 1, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Long Grove Pharms | ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 214850-001 | Jul 18, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 218047-001 | Apr 5, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Jiangxi Qingfeng | ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 218281-001 | Jun 28, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
