Viewing data from:

SOLTAMOX

NDA

TAMOXIFEN CITRATE | N021807 | MAYNE PHARMA COMMERCIAL LLC

1 strength0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Soltamox (2023)

Total Spending

$469K

Total Claims

382

Beneficiaries

Avg Cost/Unit

$4.76

Spending Trend

$48K(2021)→$393K(2022)→$469K(2023)

YoY Change:+0.3%

5yr CAGR:-0.0%

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

API Supply Chain5 active DMFs12 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

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

3 letters from Drugs@FDA

Date	Submission	Document
Apr 9, 2019	SUPPL -6	View Letter (PDF)
Oct 1, 2018	SUPPL -5	View Letter (PDF)
Nov 1, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE/10ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Oct 29, 2005

No patent or exclusivity listings for this strength.