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Last Updated: July 6, 2020

DrugPatentWatch Database Preview

TAXOL Drug Profile


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Which patents cover Taxol, and what generic alternatives are available?

Taxol is a drug marketed by Hq Spclt Pharma and is included in one NDA.

The generic ingredient in TAXOL is paclitaxel. There are sixty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

US ANDA Litigation and Generic Entry Outlook for Taxol

A generic version of TAXOL was approved as paclitaxel by TEVA PHARMS on January 25th, 2002.

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Paragraph IV (Patent) Challenges for TAXOL
Tradename Dosage Ingredient NDA Submissiondate
TAXOL INJECTABLE;INJECTION paclitaxel 020262

US Patents and Regulatory Information for TAXOL

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 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TAXOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992   Start Trial   Start Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992   Start Trial   Start Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TAXOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 2014C/037 Belgium   Start Trial PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
0961612 C00961612/01 Switzerland   Start Trial PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
1853250 CA 2014 00034 Denmark   Start Trial PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Baxter
Harvard Business School
McKesson
McKinsey

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