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NOLVADEX

NDA

TAMOXIFEN CITRATE | N017970 | 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Public Citizen Health Research Group - Citizen Petition FDA-1999-P-0026 · 4 docket documents Public Citizen and the National Women's Health Network filed this citizen petition pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA require a Medication Guide for patients and revise physician prescribing information for tamoxifen (Nolvadex) when prescribed to redu	Other	2008-11-15	Partially Denied	—

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

Clinical Trials

262 trials from ClinicalTrials.gov — 3 recruiting, 19 active, 168 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases NCT02603679	Phase 2	Active	Thomas Hatschek	181	2015-02 → 2031-12-31
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors NCT02592083	Phase 2	Active	Thomas Hatschek	10	2015-10 → 2029-02
Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors NCT01196936	Phase 2	Active	University of Alabama at Birmingham	84	2010-09 → 2028-12-11
Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer NCT04272801	Phase 2	Active	Shayna Showalter, MD	84	2020-04-07 → 2026-06-01
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread NCT02057133	Phase 1	Active	Eli Lilly and Company	198	2014-03-10 → 2026-12
Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)NCT02764541	Phase 2	Active	Dana-Farber Cancer Institute	195	2016-05-24 → 2031-04
Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer NCT03917082	Phase 2	Active	British Columbia Cancer Agency	290	2019-09-23 → 2029-05-01
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer NCT02311933	Phase 2	Active	National Cancer Institute (NCI)	81	2015-05-28 → 2027-02-02
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer NCT01674140	Phase 3	Active	SWOG Cancer Research Network	1,939	2013-09-12 → 2030-01
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)NCT00310180	Phase 3	Active	National Cancer Institute (NCI)	10,273	2006-04-07 → 2030-09-30

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

API Supply Chain5 active DMFs13 inactive

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

EXCELLA GMBH AND CO KGTAMOXIFEN CITRATE

DMF 52041983

TAPI NL BVTAMOXIFEN CITRATE USP

DMF 55001984

OLON SPATAMOXIFEN CITRATE

DMF 67351986

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDTAMOXIFEN CITRATE NON-STERILE DRUG SUBSTANCE

DMF 342972019

APITORIA PHARMA PRIVATE LTDTAMOXIFEN CITRATE USP

DMF 410842025

LEIRAS PHARMACEUTICALSInactiveTAMOXIFEN CITRATE TABLETS

DMF 47341982

LEIRAS PHARMACEUTICALSInactiveTAMOXIFEN CITRATE, BULK FORM

DMF 47931983

FUJISAWA DEUTSCHLAND GMBHInactiveTAMOXIFEN CITRATE

DMF 50601983

EGIS PHARMACEUTICALS PRIVATE LTDInactiveTAMOXIFEN CITRATE

DMF 53101984

FERMION OYInactiveTAMOXIFEN CITRATE

DMF 53631984

PCASInactiveTAMOXIFEN CITRATE

DMF 56121984

ORION CORP FARMOS CHEMICAL PLANTInactiveTAMOXIFEN (10MG. TABLET)

DMF 57771985

LACHEMA BRNOInactiveTAMOXIFEN CITRATE

DMF 95311992

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactiveTAMOXIFEN CITRATE

DMF 106811993

EGIS PHARMACEUTICALS PRIVATE LTDInactiveTAMOXIFEN CITRATE BULK

DMF 151212000

YANGTZE RIVER PHARMACY GROUP JIANGSU HAI CI BIOLOGICAL PHARMACY CO LTDInactiveTAMOXIFEN CITRATE USP

DMF 192842006

OLON SPAInactiveTAMOXIFEN CITRATE

DMF 217572008

ASYMCHEM LABORATORIES TIANJIN CO LTDInactiveTAMOXIFEN CITRATE

DMF 274662013

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2006	SUPPL -54	View Letter (PDF)
Mar 23, 2005	SUPPL -53	View Letter (PDF)
Dec 30, 2004	SUPPL -52	View Letter (PDF)
Jun 10, 2004	SUPPL -51	View Letter (PDF)
Jun 22, 2003	SUPPL -48	View Letter (PDF)
Aug 30, 2002	SUPPL -50	View Letter (PDF)
May 16, 2002	SUPPL -49	View Letter (PDF)
May 16, 2002	SUPPL -44	View Letter (PDF)
May 16, 2002	SUPPL -37	View Letter (PDF)
Jun 29, 2000	SUPPL -46	View Letter (PDF)
Oct 29, 1998	SUPPL -40	View Letter (PDF)
Oct 29, 1998	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 21, 1994