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Last Updated: March 19, 2024

PACLITAXEL Drug Patent 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, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Mylan, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Am Regent, and Teva Pharms Inc. and is included in eighteen NDAs.

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

DrugPatentWatch® 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
Cancer Cures 4 KidsPhase 1
Aston Sci. Inc.Phase 2
Chengdu Seventh People's HospitalPhase 2

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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 Strength NDA ANDAs Submitted Submissiondate
ABRAXANE For Injection Suspension paclitaxel 100 mg/vial 021660 1 2015-12-11

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Inc PACLITAXEL paclitaxel POWDER;INTRAVENOUS 216338-001 May 11, 2023 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd PACLITAXEL paclitaxel INJECTABLE;INJECTION 207326-001 Aug 23, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for PACLITAXEL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Abraxane paclitaxel EMEA/H/C/000778
Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Authorised no no no 2008-01-11
ratiopharm GmbH Pazenir paclitaxel EMEA/H/C/004441
Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Authorised yes no no 2019-05-06
Inceptua AB Apealea paclitaxel EMEA/H/C/004154
Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum‑sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
Authorised no no no 2018-11-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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