PACLITAXEL - Generic Drug Details

What are the generic sources for paclitaxel and what is the scope of patent protection?

Paclitaxel is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Actavis Totowa, Alembic, Fresenius Kabi Usa, Gland, Hikma, Hospira, MSN, Natco Pharma Usa, Pharmobedient, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Hq Spclt Pharma, Bristol-myers, Am Regent, Cipla, Hengrui Pharma, Mylan, Shuangcheng, and Teva Pharms Inc, and is included in twenty-four NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paclitaxel has one hundred and ninety-seven patent family members in thirty-one countries.

There are sixty-nine drug master file entries for paclitaxel. Twenty suppliers are listed for this compound.

Summary for PACLITAXEL

International Patents:	197
US Patents:	7
Tradenames:	3
Applicants:	22
NDAs:	24
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	4,337
Patent Applications:	6,789
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
Northwell Health	PHASE1
National Cancer Institute (NCI)	PHASE3
Andrew Hantel, MD	PHASE1

See all PACLITAXEL clinical trials

Pharmacology for PACLITAXEL

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for PACLITAXEL

Antineoplastic Agents, Phytogenic

Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for PACLITAXEL

L01CD	Taxanes
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	205720-001	Aug 17, 2018	AP	RX	No	No
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					Y
Pharmobedient	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	075278-001	Jan 25, 2002		DISCN	No	No
Fresenius Kabi Usa	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	077574-001	Nov 27, 2006	AP	RX	No	No
Hospira	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	076131-001	May 8, 2002	AP	RX	No	Yes
Natco Pharma Usa	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	091540-001	Sep 29, 2011		DISCN	No	No
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					Y

Expired US Patents for PACLITAXEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005
Bristol-myers	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
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005
Bristol-myers	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/000778Abraxane 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/004441Pazenir 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/004154Apealea 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/000216Paxene 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
Austria	E531365
Australia	2006213999	Combinations and modes of administration of therapeutic agents and combination therapy
Australia	2007317859	Nanoparticles of paclitaxel and albumin in combination with bevacizumab against cancer
Brazil	PI0607809	uso de uma composição compreendendo nanopartìculas, composição e kit
Brazil	PI0718528	NANOPARTÍCULAS DE PACLITAXEL E ALBUMINA EM COMBINAÇÃO COM BEVACIZUMABE CONTRA CÂNCER
Canada	2598239	COMBINAISONS ET MODES D'ADMINISTRATION D'AGENTS THERAPEUTIQUES ET TRAITEMENT COMBINE (COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY)
Canada	2668607	NANOPARTICULES ANTICANCEREUSES DE PACLITAXEL ET D'ALBUMINE EN COMBINAISON AVEC DU BEVACIZUMAB (COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY)

Supplementary Protection Certificates for PACLITAXEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0961612	09C0050	France		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
0961612	2009C/046	Belgium		PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
1853250	C300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250	300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
0961612	CA 2009 00036	Denmark		PRODUCT NAME: PACLITAXELALBUMIN
0961612	SZ 41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN