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Paclitaxel - Generic Drug Details

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Paclitaxel is the generic ingredient in three branded drugs marketed by Pliva Lachema, Actavis Totowa, Hospira, Accord Hlthcare, Mylan Labs Ltd, Abraxis Bioscience, Hq Spclt Pharma, Sandoz Inc, Fresenius Kabi Oncol, Mylan, Teva Pharms, Eurohlth Intl Sarl, and Teva Pharms Usa, and is included in fourteen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and five patent family members in twenty-seven countries.

There are sixty-five drug master file entries for paclitaxel. Eleven suppliers are listed for this compound.

Summary for Generic Name: paclitaxel

Tradenames:3
Patents:10
Applicants:13
NDAs:14
Drug Master File Entries: see list65
Suppliers / Packaging: see list11
Formulation / Manufacturing:see details

Pharmacology for Ingredient: paclitaxel

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule 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
Actavis Totowa
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION090130-001Dec 9, 2009RXNo<disabled><disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYes7,923,536<disabled> <disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYes<disabled><disabled>
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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)021660-001Jan 7, 20056,506,405<disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20056,753,006<disabled>
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20055,439,686<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
5,916,596 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof<disabled in preview>
8,137,684Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof<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
Australia4592997<disabled in preview>
Japan5769358<disabled in preview>
China103285395<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: PACLITAXEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
613Luxembourg<disabled>91613, EXPIRES: 20220924
00673Netherlands<disabled>PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
2014022Lithuania<disabled>PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
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