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Generated: July 21, 2017
What are the generic sources for paclitaxel and what is the scope of paclitaxel freedom to operate?
Paclitaxel is the generic ingredient in four branded drugs marketed by Pliva Lachema, Gland Pharma Ltd, Actavis Totowa, Hospira, Accord Hlthcare, Mylan Labs Ltd, Abraxis Bioscience, Hq Spclt Pharma, Sandoz Inc, Fresenius Kabi Oncol, Mylan, Teva Pharms, West-ward Pharms Int, and Teva Pharms Usa, and is included in fifteen NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 4 |
| Patents: | 14 |
| Applicants: | 14 |
| NDAs: | 15 |
| Drug Master File Entries: see list | 67 |
| Suppliers / Packagers: see list | 13 |
| Bulk Api Vendors: see list | 112 |
| Clinical Trials: see list | 2,313 |
| Patent Applications: see list | 9,748 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | paclitaxel at DailyMed |
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | AP | RX | Yes | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Gland Pharma Ltd | PACITAXEL | paclitaxel | INJECTABLE;INJECTION | 207326-001 | Aug 23, 2016 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | 7,758,891 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sandoz Inc | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 078167-001 | Dec 26, 2007 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | 9,597,409 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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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 | 6,537,579 | ► Subscribe | ||||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | 6,749,868 | ► Subscribe | ||||||||||||||||||||||
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | 6,096,331 | ► Subscribe | ||||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | 5,439,686 | ► Subscribe | ||||||||||||||||||||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | 6,753,006 | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,665,383 | Methods for the preparation of immunostimulating agents for in vivo delivery | ► Subscribe | |||||||||||||||||||||||||||
| 6,753,006 | Paclitaxel-containing formulations | ► Subscribe | |||||||||||||||||||||||||||
| 5,508,021 | Non-fluorinated polymeric shells for medical imaging | ► Subscribe | |||||||||||||||||||||||||||
| 5,512,268 | Polymeric shells for medical imaging prepared from synthetic polymers, and methods for the use thereof | ► Subscribe | |||||||||||||||||||||||||||
| 6,528,067 | Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof | ► Subscribe | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2576289 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1944019 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 5035900 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2006213999 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 4661097 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 613 | Luxembourg | ► Subscribe | 91613, EXPIRES: 20220924 | ||||||||||||||||||||||||||
| /2014 | Austria | ► Subscribe | PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230 | ||||||||||||||||||||||||||
| 2014022 | Lithuania | ► Subscribe | PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 | ||||||||||||||||||||||||||
| 2009 00036 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 8 50005-2014 | Slovakia | ► Subscribe | PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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