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, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Norvium Bioscience, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Hq Spclt Pharma, Bristol-myers, Am Regent, Hengrui Pharma, and Teva Pharms Inc, and is included in twenty-one 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. Nineteen suppliers are listed for this compound.

Summary for PACLITAXEL

International Patents:	242
US Patents:	11
Tradenames:	3
Applicants:	19
NDAs:	21
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	3,817
Patent Applications:	445
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
Vall d'Hebron Institute of Oncology	Phase 2
Lee Ocuin, MD	Phase 2
L-Nutra Inc	N/A

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
Msn	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	213434-001	Aug 24, 2020	AP	RX	No	No
Am Regent	PACLITAXEL	paclitaxel	POWDER;INTRAVENOUS	211875-001	Jul 27, 2022	AB	RX	Yes	Yes
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					Y
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992		DISCN	Yes	No
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes

Expired US Patents for PACLITAXEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992
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/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
South Korea	20140016402	COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY
European Patent Office	2552415	MÉTHODES DE TRAITEMENT DU CANCER (METHODS OF TREATING CANCER)
South Korea	20170016017	암에 대항하는 베바시주맙과 조합된 파클리탁셀 및 알부민의 나노입자 (Nanoparticles of Paclitaxel and Albumin in Combination with Bevacizumab against Cancer)
South Korea	101625347
Poland	1853250
Japan	2014218517	眼の疾患及び障害治療用のアミン誘導体化合物 (AMINE DERIVATIVE COMPOUNDS FOR TREATMENT OF EYE DISEASES AND DISORDERS)

Supplementary Protection Certificates for PACLITAXEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
0961612	SZ 41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN
1853250	132014902271575	Italy		PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 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	37/2014	Austria		PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
0961612	132009901771196	Italy		PRODUCT NAME: PACLITAXEL(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/428/001, 20080114