ABRAXANE Drug Patent Profile

Which patents cover Abraxane, and what generic alternatives are available?

Abraxane is a drug marketed by Abraxis Bioscience and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Abraxane

A generic version of ABRAXANE was approved as paclitaxel by TEVA PHARMS on January 25^th, 2002.

Summary for ABRAXANE

International Patents:	241
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	422
Patent Applications:	4,461
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ABRAXANE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABRAXANE
What excipients (inactive ingredients) are in ABRAXANE?	ABRAXANE excipients list
DailyMed Link:	ABRAXANE at DailyMed

See drug prices for ABRAXANE

Recent Clinical Trials for ABRAXANE

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

Sponsor	Phase
Devalingam Mahalingam	Phase 1/Phase 2
Amgen	Phase 1/Phase 2
CSPC Ouyi Pharmaceutical Co., Ltd.	Phase 1

See all ABRAXANE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ABRAXANE

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

Paragraph IV (Patent) Challenges for ABRAXANE

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 ABRAXANE

ABRAXANE is protected by eleven US patents and two FDA Regulatory Exclusivities.

Patents protecting ABRAXANE

FDA Regulatory Exclusivity protecting ABRAXANE

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

Expired US Patents for ABRAXANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005

International Patents for ABRAXANE

See the table below for patents covering ABRAXANE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5926724
Japan	2018087235	膵臓がんの処置方法 (METHODS OF TREATING PANCREATIC CANCER)
Japan	2020011999	組成物及び薬物送達方法 (COMPOSITION AND METHOD OF DELIVERY OF PHARMACOLOGICAL AGENT)

Supplementary Protection Certificates for ABRAXANE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0961612	300417	Netherlands		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
0961612	09C0050	France		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
1853250	300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220