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Paclitaxel - Generic Drug Details
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This ingredient has two hundred and twenty-six patent family members in twenty-nine countries.
There are sixty-five drug master file entries for paclitaxel. Eleven suppliers are listed for this compound.
Summary for Generic Name: paclitaxel
| Tradenames: | 4 |
| Patents: | 11 |
| Applicants: | 14 |
| NDAs: | 15 |
| Drug Master File Entries: see list | 65 |
| Suppliers / Packaging: see list | 11 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: paclitaxel
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Clinical Trials for: paclitaxel
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms Usa | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 075297-001 | Jan 25, 2002 | DISCN | No | ||||||||||||||||||||||
Hospira | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 076131-001 | May 8, 2002 | RX | Yes | ||||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Sep 6, 2020 | |||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: paclitaxel
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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 | 6,096,331 | <disabled> | ||||||||||||||||||||||
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | 5,641,803 | <disabled> | ||||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | 5,439,686 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: paclitaxel
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,096,331 | Methods and compositions useful for administration of chemotherapeutic agents | <disabled in preview> | |||||||||||||||||||||||||||
| 5,639,473 | Methods for the preparation of nucleic acids for in vivo delivery | <disabled in preview> | |||||||||||||||||||||||||||
| 5,997,904 | Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof | <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 Ingredient: paclitaxel
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Portugal | 1853250 | <disabled in preview> | |||||||||||||||||||||||||||
| Russian Federation | 2009110382 | <disabled in preview> | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2006089290 | <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.
Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: PACLITAXEL
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00673 | Netherlands | <disabled> | PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 | ||||||||||||||||||||||||||
| 0673 | Netherlands | <disabled> | PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 | ||||||||||||||||||||||||||
| 613 | Luxembourg | <disabled> | 91613, EXPIRES: 20220924 | ||||||||||||||||||||||||||
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How are People Using DrugPatentWatch?
For data on generic availability, patent expirations, legal action that postpones generic launch
— Clinical pharmacist, USA
To identify producers of specific APIs
— Market research, Germany
To find manufacturing sources for registration and sales in Sweden
— Pharmaceutical whoesaler, Sweden
To obtain drug patent information
— Patent analyst, India
For access to patents for competitive analysis and project managment
— Pharmaceutical industry consultant, USA
For information on products (NDAs and ANDAs) that I may be interested in developing, licensing or acquiring
— Executive, specialty pharmaceutical company, USA
To follow up IP status of APIs in the Commonwealth of Independent States
— API wholesaler, UK
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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