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Last Updated: July 6, 2020

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PACLITAXEL Drug Profile


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Which patents cover Paclitaxel, and when can generic versions of Paclitaxel launch?

Paclitaxel is a drug marketed by Accord Hlthcare, Actavis Totowa, Fresenius Kabi Usa, Hospira, Mylan, Mylan Labs Ltd, Pliva Lachema, Sandoz Inc, Teva Pharms, Teva Pharms Usa, and West-ward Pharms Int. and is included in thirteen NDAs.

The generic ingredient in PACLITAXEL 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 Paclitaxel

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

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Drug patent expirations by year for PACLITAXEL
Drug Prices for PACLITAXEL

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Recent Clinical Trials for PACLITAXEL

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SponsorPhase
Adlai Nortye Biopharma Co., Ltd.Phase 3
Brooklyn ImmunoTherapeutics, LLCPhase 2
Providence Health & ServicesPhase 2

See all PACLITAXEL clinical trials

Pharmacology for PACLITAXEL
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for PACLITAXEL
Paragraph IV (Patent) Challenges for PACLITAXEL
Tradename Dosage Ingredient NDA Submissiondate
ABRAXANE FOR SUSPENSION;IV (INFUSION) paclitaxel 021660 2015-12-11
TAXOL INJECTABLE;INJECTION paclitaxel 020262

US Patents and Regulatory Information for PACLITAXEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare PACLITAXEL paclitaxel INJECTABLE;INJECTION 075436-001 Nov 12, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan PACLITAXEL paclitaxel INJECTABLE;INJECTION 075278-001 Jan 25, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa PACLITAXEL paclitaxel INJECTABLE;INJECTION 077574-001 Nov 27, 2006 AP RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa PACLITAXEL paclitaxel INJECTABLE;INJECTION 075297-001 Jan 25, 2002 DISCN No 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Moodys
McKinsey
Mallinckrodt
Colorcon

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