Viewing data from:

KENALOG-40

NDA

TRIAMCINOLONE ACETONIDE | N014901 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

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

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 Kenalog-40 (2023)

Total Spending

$26K

Total Claims

1,191

Beneficiaries

945

Avg Cost/Unit

$1.04

Spending Trend

$154K(2019)→$64K(2020)→$41K(2021)→$35K(2022)→$26K(2023)

YoY Change:+5.5%

5yr CAGR:-15.6%

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

API Supply Chain12 active DMFs14 inactive

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

TAPI NL BVTRIAMCINOLONE ACETONIDE

DMF 47121982

FARMABIOS SPATRIAMCINOLONE ACETONIDE

DMF 146932000

TIANJIN TIANYAO PHARMACEUTICALS CO LTDTRIAMCINOLONE ACETONIDE USP

DMF 190962006

CURIA SPAIN SAUTRIAMCINOLONE ACETONIDE STERILE MICRONIZED, USP

DMF 211732007

SYMBIOTEC PHARMALAB PRIVATE LTDTRIAMCINOLONE ACETONIDE USP

DMF 212632008

FARMABIOS SPATRIAMCINOLONE ACETONIDE MICRONIZED STERILE

DMF 215912008

EUROAPI FRANCETRIAMCINOLONE ACETONIDE

DMF 229472009

NEWCHEM SPATRIAMCINOLONE ACETONIDE MICRONIZED

DMF 245432011

CORAL DRUGS PRIVATE LTDTRIAMCINOLONE ACETONIDE

DMF 313572017

SHANDONG SIRUI PHARMACEUTICAL CO LTDTRIAMCINOLONE ACETONIDE

DMF 363132022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTRIAMCINOLONE ACETONIDE

DMF 398652024

HENAN LIHUA PHARMACEUTICAL CO LTDTRIAMCINOLONE ACETONIDE

DMF 398972024

ANTIBIOTICOS SPAInactiveTRIAMCINOLONE ACETONIDE

DMF 26511976

PIERREL SPAInactiveTRIAMCINOLONE ACETONIDE

DMF 26551976

MANUFACTURING ENTERPRISES INCInactiveTRIAMCINOLONE ACETONIDE 10%

DMF 27251976

ER SQUIBB AND SONS INCInactiveTRIAMCINOLONE ACETONIDE CONCENTRATE

DMF 27411976

GYMA LABORATORIES AMERICA INCInactiveTRIAMCINOLONE ACETONIDE

DMF 29491977

DIOSYNTH BVInactiveTRIAMCINOLONE ACETONIDE MICRO

DMF 37631980

ROUSSELL UCLAFInactiveTRIAMCINOLONE ACETONIDE

DMF 40851981

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveTRIAMCINOLONE ACETONIDE USPXX

DMF 41971981

FARMABOISInactiveTRIAMCINOLONE ACETONIDE

DMF 49571983

HOECHST MARION ROUSSEL SAInactiveTRIAMCINOLONE ACETONIDE

DMF 63671986

QUATRUMInactiveTRIAMCINOLONE ACETONIDE

DMF 64971986

PFIZER INCInactiveTRIAMCINOLONE ACETONIDE

DMF 88211990

NANOSYSTEMSInactiveTRIAMCINOLONE ACETONIDE NANOCRYSTAL COLLOIDAL DISPERSION

DMF 121811996

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTRIAMCINOLONE ACETONIDE MICRONIZED STERILE

DMF 216582008

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Nov 18, 2024	SUPPL -55	View Letter (PDF)
Jun 7, 2024	SUPPL -54	View Letter (PDF)
May 19, 2020	SUPPL -47	View Letter (PDF)
Apr 1, 2018	SUPPL -44	View Letter (PDF)
Jul 8, 2014	SUPPL -42	View Letter (PDF)
Jul 19, 2011	SUPPL -39	View Letter (PDF)
Jun 17, 2011	SUPPL -38	View Letter (PDF)
Feb 5, 2010	SUPPL -37	View Letter (PDF)
Dec 4, 2006	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG/ML

RLDAB

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 80MG/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 12, 2019