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ABRAXANE Drug Profile
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This drug has two hundred and twenty-six patent family members in twenty-nine countries.
The generic ingredient in ABRAXANE is paclitaxel. There are sixty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Summary for Tradename: ABRAXANE
| Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Drug Prices: : | see details |
Pharmacology for Tradename: ABRAXANE
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Clinical Trials for: ABRAXANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | 7,923,536 | Dec 9, 2023 | ||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Sep 6, 2016 | |||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | 8,314,156 | Dec 9, 2023 | ||||||||||||||||||||
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Expired Patents for Tradename: ABRAXANE
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RE41884 | <disabled> | ||||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | 5,439,686 | <disabled> | ||||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | 6,749,868 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: ABRAXANE
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| paclitaxel protein-bound particles | For Injection Suspension | 100 mg/vial | Abraxane | 12/11/2015 |
Non-Orange Book Patents for Tradename: ABRAXANE
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,137,684 | Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof | <disabled in preview> | |||||||||||||||||||||||||||
| 5,665,382 | Methods for the preparation of pharmaceutically active agents for in vivo delivery | <disabled in preview> | |||||||||||||||||||||||||||
| 7,780,984 | Methods and compositions for treating proliferative diseases | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Tradename: ABRAXANE
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 0189522 | <disabled in preview> | |||||||||||||||||||||||||||
| New Zealand | 628423 | <disabled in preview> | |||||||||||||||||||||||||||
| Russian Federation | 2007134571 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: ABRAXANE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 613 | Luxembourg | <disabled> | 91613, EXPIRES: 20220924 | ||||||||||||||||||||||||||
| 2014022 | Lithuania | <disabled> | PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 | ||||||||||||||||||||||||||
| 2009 00036 | Denmark | <disabled> | |||||||||||||||||||||||||||
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