Viewing data from:

PACLITAXEL

ANDA

PACLITAXEL | A209657 | CIPLA LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ABRAXANE(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ABRAXIS BIOSCIENCE, LLC et al v. CIPLA LTD. 2:2016cv09074 4 patentsANDA 209657paclitaxel protein-bound particles for injectable suspension	D.N.J.	2016-12-07	Terminated 2018-10-09	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain25 active DMFs36 inactive

18 active API suppliers hold Drug Master Files for this ingredient.

YUNNAN HANDE BIO-TECH CO LTDPACLITAXEL DRUG SUBSTANCE

DMF 119091996

SERIPHARM SASPACLITAXEL

DMF 122941996

SAMYANG HOLDINGS CORPPACLITAXEL

DMF 143381999

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDPACLITAXEL

DMF 153192001

INDENA SPAPACLITAXEL P.I.

DMF 162422002

CORDEN PHARMA BOULDER INCPACLITAXEL DRUG SUBSTANCE

DMF 164392003

SCINOPHARM TAIWAN LTDPACLITAXEL USP

DMF 166762003

TAPI NL BVPACLITAXEL

DMF 167012003

GUILIN HUIANG BIOCHEMISTRY PHARMACEUTICAL CO LTDPACLITAXEL DRUG SUBSTANCE

DMF 170452003

YUNNAN HANDE BIO-TECH CO LTDPACLITAXEL DRUG SUBSTANCE ISOLATED FROM TAXUS CANADENSIS

DMF 191112006

TAPI NL BVPACLITAXEL SEMISYNTHETIC

DMF 235062010

PHYTON BIOTECH LLCPACLITAXEL PRODUCED BY PLANT CELL FERMENTATION USP

DMF 255252011

FUJIAN SOUTH PHARMACEUTICAL CO LTDPACLITAXEL (SEMI-SYNTHETIC) USP NON STERILE BULK DRUG SUBSTANCE

DMF 258222012

HETERO LABS LTDPACLITAXEL USP

DMF 266882012

INTAS PHARMACEUTICALS LTDPACLITAXEL USP (SEMI-SYNTHETIC)

DMF 267922013

HAINAN YEW PHARMACEUTICAL CO LTDPACLITAXEL (SEMI-SYNTHETIC)

DMF 270492013

YUNNAN HANDE BIO-TECH CO LTDPACLITAXEL DRUG SUBSTANCE, SEMI-SYNTHESIZED FROM 10-DAB

DMF 274862013

SCINOPHARM TAIWAN LTDPACLITAXEL USP

DMF 275672014

TAPI NL BVPACLITAXEL SEMISYNTHETIC (FROM 10-DAB)

DMF 304542016

TAPI NL BVPACLITAXEL SEMISYNTHETIC (9-DHB)

DMF 305372016

MSN LABORATORIES PRIVATE LTDPACLITAXEL USP

DMF 321942017

WUHAN CALMLAND PHARMACEUTICALS CO LTDPACLITAXEL

DMF 325122018

APITORIA PHARMA PRIVATE LTDPACLITAXEL USP

DMF 362282021

INTAS PHARMACEUTICALS LTDPACLITAXEL (SEMI SYNTHETIC) USP (PROCESS-II)

DMF 362532021

CHONGQING SINTAHO PHARMACEUTICAL CO LTDPACLITAXEL (SEMI-SYNTHETIC)

DMF 364792021

NAPRO BIOTHERAPEUTICS INCInactivePACLITAXEL DRUG SUBSTANCE

DMF 105041993

HAUSER CHEMICAL RESEARCH INCInactivePACLITAXEL

DMF 112481995

NAPRO BIOTHERAPEUTICS INCInactivePACLITAXEL DRUG SUBSTANCE

DMF 118411996

GREEN SPRINGS BIOCHEMISTRYInactivePACLITAXEL

DMF 120691996

PHYTOGEN LIFE SCIENCES INCInactivePACLITAXEL

DMF 121301996

XECHEM INCInactivePACLITAXEL BULK DRUG SUBSTANCE

DMF 125441997

INDENA SPAInactivePACLITAXEL

DMF 128761998

CSF BIOTECHInactivePACLITAXEL

DMF 130161998

CHONGQING UNIT MODERN TECHNOLOGY CO LTDInactivePACLITAXEL

DMF 131481998

HUIANG BIO CHEMICAL PRODUCT MANUFACTURE COMPANY LTDInactivePACLITAXEL

DMF 138261998

KUNMING INSTITUTE OF BOTANYInactivePACLITAXEL (TAXOL)

DMF 139801999

NAPRO BIOTHERAPEUTICS INCInactivePACLITAXEL DRUG SUBSTANCE

DMF 143501999

CHROMADEX INCInactivePACLITAXEL

DMF 143891999

LD PHARMACEUTICALInactivePACLITAXEL

DMF 144031999

BIOXEL PHARMA INCInactivePACLITAXEL

DMF 145031999

NATURAL PHARMACEUTICALS INCInactivePACLITAXEL API, ISOLATION AND PURIFICATION FROM TAXUS BREVIFOLIA

DMF 147062000

HOSPIRA BOULDER INCInactivePACLITAXEL EXTRACT

DMF 150792000

HOSPIRA BOULDER INCInactivePACLITAXEL DRUG SUBSTANCE

DMF 150922000

THERAPLEX CORPInactivePACLITAXEL SUBSTANCE

DMF 151622000

SOUTHERN HERBALS LTDInactivePACLITAXEL DRUG SUBSTANCE

DMF 152002000

TAIHUA NATURAL PLANT PHARMACEUTICAL CO LTDInactivePACLITAXEL

DMF 153822001

XIAN HIGH TECH INDUSTRIES CO LTDInactivePACLITAXEL

DMF 159612002

CHONGQING UNITED PHARMACEUTICAL CO LTDInactivePACLITAXEL DRUG SUBSTANCE

DMF 168912003

PAXIS PHARMACEUTICALSInactivePACLITAXEL DRUG SUBSTANCE

DMF 174572004

ACCORD HEALTHCARE INCInactivePACLITAXEL API

DMF 176502004

FRESENIUS KABI ONCOLOGY LTDInactivePACLITAXEL SEMISYNTHETIC

DMF 179662004

POLYMED THERAPEUTICS INCInactivePACLITAXEL DRUG SUBSTANCE

DMF 183972005

CHONGQING UNITED PHARMACEUTICAL CO LTDInactivePACLITAXEL DRUG SUBSTANCE

DMF 191592006

SHANGHAI JINSHAN BIOTECH CO LTDInactivePACLITAXEL

DMF 192932006

BEIJING YI HE BIOTECH CO LTDInactivePACLITAXEL USP, NON-STERILE BULK

DMF 194212006

SAI PHYTOCEUTICALS PVT LTDInactivePACLITAXEL

DMF 196602006

FUJIAN SOUTH PHARMACEUTICAL CO LTDInactivePACLITAXEL (NATURAL) USP (NATURAL, NON-STERILE BULK DRUG SUBSTANCE)

DMF 235582010

JIANGSU YEW PHARMACEUTICAL CO LTDInactivePACLITAXEL

DMF 257592012

MAC CHEM PRODUCTS INDIA PVT LTDInactivePACLITAXEL USP

DMF 258432012

ARCH PHARMALABS LTDInactivePACLITAXEL USP (SEMI-SYNTHETIC)

DMF 258702012

POLYMED THERAPEUTICS INCInactivePACLITAXEL USP (SEMI-SYNTHETIC)

DMF 279002014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 100MG/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Apr 10, 2025

No patent or exclusivity listings for this strength.