Paclitaxel - Generic Drug Details

What are the generic sources for paclitaxel and what is the scope of freedom to operate?

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

Paclitaxel has two hundred and forty-two patent family members in thirty-one countries.

There are sixty-nine drug master file entries for paclitaxel. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for paclitaxel

International Patents:	242
US Patents:	11
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	3,593
Patent Applications:	1,467
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for paclitaxel
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paclitaxel
What excipients (inactive ingredients) are in paclitaxel?	paclitaxel excipients list
DailyMed Link:	paclitaxel at DailyMed

See drug prices for paclitaxel

Recent Clinical Trials for paclitaxel

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Institut de cancérologie Strasbourg Europe	Phase 3
University Hospital Heidelberg	Phase 1
German Cancer Research Center	Phase 1

See all paclitaxel clinical trials

Generic filers with tentative approvals for PACLITAXEL

Applicant	Application No.	Strength	Dosage Form
		100MG	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for paclitaxel

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for paclitaxel

Antineoplastic Agents, Phytogenic

Tubulin Modulators

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
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005		RX	Yes	Yes					Y
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005		RX	Yes	Yes					Y
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005		RX	Yes	Yes					Y
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005		RX	Yes	Yes					Y

Expired US Patents for paclitaxel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005

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
Norton Healthcare Ltd.	Paxene	paclitaxel	EMEA/H/C/000216 Paxene is indicated for the treatment of patients with:• advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy;• metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy;• advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment;• metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment;• non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1).	Withdrawn	no	no	no	1999-07-19

International Patents for paclitaxel

Country	Patent Number	Title	Estimated Expiration
Portugal	2097078
China	103285395	Combinations and modes of administration of therapeutic agents and combination therapy
China	103169729	Methods and compositions for treating proliferative diseases
China	104940929	Nanoparticles of paclitaxel and albumin in combination with bevacizumab against cancer

Supplementary Protection Certificates for paclitaxel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250	2014C/037	Belgium		PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
1853250	C300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612	09C0050	France		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111