Viewing data from:

FASLODEX

NDA

FULVESTRANT | N021344 | ASTRAZENECA PHARMACEUTICALS LP

2 strengths0 unique patents0 unique exclusivities

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
ASTRAZENECA PHARMACEUTICALS LP et al v. HBT LABS, INC. 1:2017cv02652 4 patentsANDA 209714fulvestrant	D.N.J.	2017-04-18	Terminated 2017-09-11	—
ASTRAZENECA PHARMACEUTICALS LP et al v. MYLAN PHARMACEUTICALS INC. et al 1:2015cv07009 4 patentsANDA 207640fulvestrant	D.N.J.	2015-09-21	Terminated 2015-12-08	—
ASTRAZENECA PHARMACEUTICALS LP et al v. AGILA SPECIALTIES, INC et al 1:2015cv06039 4 patentsANDA 207640fulvestrant	D.N.J.	2015-08-06	Terminated 2017-10-27	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Teva Pharmaceuticals USA, Inc. FDA-2019-P-3937 Teva Pharmaceuticals USA, Inc. filed this citizen petition requesting that the FDA assign a therapeutic equivalence code of "AO" to Teva's Fulvestrant Injection, 250 mg/5 ml (50 mg/ml), which was approved under NDA 210063 on August 19, 2019 pursuant to Section 505(b)(2) of the Federal Food, Drug and	Other	2019-08-21	Denied	Teva Pharmaceuticals USA

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

9 trials from ClinicalTrials.gov — 6 recruiting, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy.NCT07666555	Phase 2	Recruiting	Fudan University	98	2026-06-06 → 2029-12-30
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors NCT06726148	Phase 1/2	Recruiting	Novartis Pharmaceuticals	280	2025-04-03 → 2028-09-25
A Study of LY4257496 in Participants With Cancer (OMNIRAY)NCT07114601	Phase 1	Recruiting	Eli Lilly and Company	421	2025-08-06 → 2035-04
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer NCT06756932	Phase 1	Recruiting	BeOne Medicines	120	2025-02-04 → 2027-07-30
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors NCT06993844	Phase 1/2	Recruiting	Ensem Therapeutics	233	2025-06-10 → 2027-12-30
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors NCT06625775	Phase 1	Recruiting	TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)	392	2024-10-29 → 2028-11
Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies NCT03363893	Phase 1/2	Completed	Carrick Therapeutics Limited	124	2017-11-14 → 2022-12-15
A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors NCT02792465	Phase 1	Completed	University Health Network, Toronto	52	2016-11-11 → 2025-06-12
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment NCT05631795	Phase 4	Completed	Novartis Pharmaceuticals	40	2022-08-09 → 2025-06-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Faslodex (2023)

Total Spending

$293K

Total Claims

163

Beneficiaries

Avg Cost/Unit

$176.67

Spending Trend

$7.2M(2019)→$1.6M(2020)→$670K(2021)→$444K(2022)→$293K(2023)

YoY Change:-7.0%

5yr CAGR:-2.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Faslodex (2023)

Total Spending

$27.1M

Total Claims

129,237

Beneficiaries

17,199

ASP Price

—

HCPCS: J9395 — Injection, fulvestrant, 25 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

26 letters from Drugs@FDA

Date	Submission	Document
Jan 21, 2021	SUPPL -44	View Letter (PDF)
Jul 29, 2020	SUPPL -42	View Letter (PDF)
May 14, 2020	SUPPL -41	View Letter (PDF)
Nov 22, 2019	SUPPL -38	View Letter (PDF)
May 22, 2019	SUPPL -39	View Letter (PDF)
Mar 12, 2019	SUPPL -37	View Letter (PDF)
Jul 6, 2018	SUPPL -36	View Letter (PDF)
Nov 15, 2017	SUPPL -35	View Letter (PDF)
Aug 28, 2017	SUPPL -34	View Letter (PDF)
Jan 27, 2017	SUPPL -33	View Letter (PDF)
Oct 31, 2016	SUPPL -31	View Letter (PDF)
Jul 13, 2016	SUPPL -29	View Letter (PDF)
May 20, 2016	SUPPL -27	View Letter (PDF)
Mar 4, 2016	SUPPL -26	View Letter (PDF)
Mar 3, 2016	SUPPL -25	View Letter (PDF)
Nov 13, 2012	SUPPL -19	View Letter (PDF)
Nov 13, 2012	SUPPL -20	View Letter (PDF)
Jul 17, 2012	SUPPL -18	View Letter (PDF)
Sep 29, 2011	SUPPL -15	View Letter (PDF)
Sep 29, 2011	SUPPL -14	View Letter (PDF)
May 19, 2011	SUPPL -13	View Letter (PDF)
Sep 13, 2010	SUPPL -12	View Letter (PDF)
Sep 13, 2010	SUPPL -7	View Letter (PDF)
Aug 8, 2005	SUPPL -4	View Letter (PDF)
Jan 14, 2004	SUPPL -1	View Letter (PDF)
Apr 25, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG/5ML (50MG/ML)

RLDAO

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Apr 25, 2002

No patent or exclusivity listings for this strength.

#002 — 125MG/2.5ML (50MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR | Approved: Apr 25, 2002