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Paclitaxel - Generic Drug Details

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

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

Paclitaxel has three hundred and fifty-one patent family members in thirty-one countries.

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

Summary for paclitaxel

International Patents:	351
US Patents:	12
Tradenames:	4
Applicants:	15
NDAs:	17
Drug Master File Entries:	69
Suppliers / Packagers:	11
Bulk Api Vendors:	84
Clinical Trials:	3,039
Patent Applications:	6,738
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for paclitaxel
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paclitaxel
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
CSPC-NBP Pharmaceutical Co., Ltd.	Phase 2
Conjupro Biotherapeutics, Inc.	Phase 2
Ipsen	Phase 2

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

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
Pliva Lachema	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	077413-001	Mar 12, 2008		DISCN	No	No
Msn	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	213434-001	Aug 24, 2020	AP	RX	No	No
Mylan	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	075278-001	Jan 25, 2002		DISCN	No	No
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005		RX	Yes	Yes
Accord Hlthcare	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	205720-001	Aug 17, 2018		DISCN	No	No
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005		RX	Yes	Yes
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	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	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	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

International Patents for paclitaxel

Country	Patent Number	Estimated Expiration
Russian Federation	2452482
Japan	2020012005
Australia	718753
Norway	20092179
Cyprus	1120625
Japan	2009185042
Russian Federation	2005121569

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	2009C/046	Belgium		PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
0961612	09C0050	France		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
1853250	132014902271575	Italy		PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
0961612	132009901771196	Italy		PRODUCT NAME: PACLITAXEL(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/428/001, 20080114
0961612	C00961612/01	Switzerland		PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
0961612	CA 2009 00036	Denmark		PRODUCT NAME: PACLITAXELALBUMIN