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FULVESTRANT

ANDA

FULVESTRANT | A210044 | AMNEAL EU LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: FASLODEX(TE code: AO)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ASTRAZENECA PHARMACEUTICALS LP et al v. AMNEAL PHARMACEUTICALS LLC 1:2017cv01968 4 patentsANDA 210044fulvestrant	D.N.J.	2017-03-24	Terminated 2018-03-23	—

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

API Supply Chain14 active DMFs2 inactive

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

SCINOPHARM TAIWAN LTDFULVESTRANT USP

DMF 226112009

TAPI NL BVFULVESTRANT

DMF 268352013

STERLING SPAFULVESTRANT

DMF 268552013

INDUSTRIALE CHIMICA SRLFULVESTRANT USP

DMF 291042015

WAVELENGTH ENTERPRISES LTDFULVESTRANT

DMF 294462015

GLAND PHARMA LTDFULVESTRANT USP

DMF 297872015

HANGZHOU JIUYUAN GENE ENGINEERING CO LTDFULVESTRANT

DMF 298872015

WISDOM PHARMACEUTICAL CO LTDFULVESTRANT INTERMEDIATE

DMF 301992016

FARMABIOS SPAFULVESTRANT

DMF 329492018

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDFULVESTRANT

DMF 339022020

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDFULVESTRANT USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 340532019

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDFULVESTRANT INTERMEDIATE (CAS NO.: 875573-66-3)

DMF 374692022

STEROID SPAFULVESTRANT

DMF 381782023

CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO LTDFULVESTRANT

DMF 408992024

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveFULVESTRANT

DMF 221742008

CHEM WERTH INCInactiveFULVESTRANT

DMF 268932014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 26, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/5ML (50MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Mar 4, 2019

No patent or exclusivity listings for this strength.