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FULVESTRANT

NDA

FULVESTRANT | N210326 | FRESENIUS KABI USA LLC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

9271990

May. 17, 2034

9833459

Feb. 14, 2034

10188663

Feb. 14, 2034

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca Pharmaceuticals LP et al v. Fresenius Kabi USA, LLC 1:2017cv01795 4 patentsfulvestrant	D. Del.	2017-12-14	Terminated 2018-01-22	—
ASTRAZENECA PHARMACEUTICALS LP et al v. FRESENIUS KABI USA, LLC 1:2017cv13075 4 patentsfulvestrant	D.N.J.	2017-12-14	Terminated 2018-02-02	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

3 letters from Drugs@FDA

Date	Submission	Document
May 13, 2021	SUPPL -1	View Letter (PDF)
May 13, 2021	SUPPL -2	View Letter (PDF)
Oct 22, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/5ML (50MG/ML)

3 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: May 20, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9271990	May 17, 2034	—	—	Yes	—
9833459	Feb 14, 2034	—	—	Yes	—
10188663	Feb 14, 2034	—	—	Yes	—