Viewing data from:

KENALOG-10

NDA

TRIAMCINOLONE ACETONIDE | N012041 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from AuroMedics Pharma LLC FDA-2018-P-3599 · 4 docket documents AuroMedics Pharma LLC, the U.S. agent for Aurobindo Pharma Limited, filed this petition requesting that FDA determine the original formulation of NDA 012041 for Kenalog-10 (Triamcinolone Acetonide Injectable Suspension, USP 10 mg per mL) was not discontinued for safety or efficacy reasons and may be	505(q)	2018-09-25	Granted	AuroMedics Pharma LLC

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

Clinical Trials

137 trials from ClinicalTrials.gov — 2 recruiting, 83 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study NCT04207931	Phase 4	Recruiting	Wake Forest University Health Sciences	250	2018-04-30 → 2027-03
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study NCT02025023	Phase 3	Recruiting	University of Washington	120	2013-12 → 2026-07
Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy NCT00373282	Phase 3	Completed	Shahid Beheshti University of Medical Sciences	—	2001-06 → 2003-06
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy NCT00411333	Early Phase 1	Completed	National Eye Institute (NEI)	100	2006-07 → 2009-07
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.NCT01080131	Phase 3	Completed	Novartis Pharmaceuticals	226	2010-03 → 2011-10
Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema NCT00874744	Phase 2	Completed	Universidade Federal de Goias	13	2008-03 → 2008-10
The Efficacy of Topical Bupivacaine and Triamcinolone Acetonide Injection in the Relief of Pain After Endoscopic Submucosal Dissection for Gastric Neoplasia: A Randomized Double-blind, Placebo-controlled Trial NCT01961752	N/A	Completed	Yonsei University	111	2012-07 → 2013-04
Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome NCT02708693	N/A	Completed	Taipei Veterans General Hospital, Taiwan	52	2013-04 → 2014-06
Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis NCT02022930	Phase 3	Completed	Carbylan Therapeutics, Inc.	510	2014-01 → 2016-06
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib NCT00242580	Phase 3	Completed	Novartis Pharmaceuticals	111	2005-09

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$2.32

per ml

Lowest NADAC/Unit

$2.32

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00003049420KENALOG-10 50 MG/5 ML VIAL	$2.32	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$8.90

Highest Price

$10.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00003-0494-20KENALOG-10 INJ	$10.93	FSS	Bristol-Myers Squibb Company	04/30/2029
00003-0494-20KENALOG-10 INJ	$8.90	Big4	Bristol-Myers Squibb Company	04/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Kenalog-10 (2024)

Total Spending

$6K

Total Claims

284

Beneficiaries

177

Avg Cost/Unit

$2.71

Spending Trend

$11K(2019)→$8K(2020)→$7K(2021)→$7K(2022)→$6K(2023)→$6K(2024)

YoY Change:+108.1%

5yr CAGR:+26.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs15 inactive

12 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

VAMSI LABS LTDTRIAMCINOLONE ACETONIDE USP

DMF 425952026

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

CHEMSERVICES INCInactiveTRIAMCINOLONE ACETONIDE, USP IN THE EAST HANOVER, NJ FACILITIES

DMF 37951980

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
Sep 24, 2024	SUPPL -52	View Letter (PDF)
Jun 7, 2024	SUPPL -51	View Letter (PDF)
Jun 27, 2018	SUPPL -45	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 -36	View Letter (PDF)
Dec 4, 2006	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.