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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2016-P-1825 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA Commissioner determine whether the original formulation of Kenalog-40 (triamcinolone acetonide) Injectable Suspension, approved under NDA 014901, was withdrawn for safety or effectiveness reasons, and	505(q)	2016-06-28	GrantedUnverified summary	Lachman Consultant Services, Inc.

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

Clinical Trials

159 trials from ClinicalTrials.gov — 12 recruiting, 2 active, 93 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields NCT04469075	Phase 2	Active	Memorial Sloan Kettering Cancer Center	48	2020-07-09 → 2027-07
Corticosteroid Meniscectomy Randomized Trial NCT04641351	Phase 4	Active	The Cleveland Clinic	150	2021-05-27 → 2027-08-01
Carbon Dioxide Laser-Assisted Delivery of Triamcinolone With or Without 5-Fluorouracil for Hypertrophic Burn Scars NCT07660120	N/A	Not Yet Recruiting	University of California, Davis	65	2026-08-22 → 2028-07-10
Efficacy of Clobetasol Vs Intralesional Triamcinolone in Lichen Planus Treatment NCT07666620	Phase 4	Not Yet Recruiting	Noor Aziz	50	2026-10-01 → 2027-04-30
Management of Postoperative Complications After Mandibular Third Molar Extraction Using Submucosal Triamcinolone Injection, Kinesiology Taping, and Standard Care NCT07719270	N/A	Not Yet Recruiting	Allama Iqbal Medical College	60	2027-01-01 → 2029-01-01
Pre-emptive Insulin to Prevent High Glucose After a Knee Steroid Injection in Adults With Type 2 Diabetes NCT07757464	Phase 1/2	Not Yet Recruiting	Shifa International Hospital	125	2026-08-10 → 2027-01-30
Dropless Pars Plana Vitrectomy Study NCT05331664	Phase 4	Recruiting	Massachusetts Eye and Ear Infirmary	168	2022-07-25 → 2027-01-30
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
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
Triamcinolone Nanocapsules After Endoscopic Nasal Surgery NCT07714525	Phase 2	Recruiting	Deraya University	50	2026-05-01 → 2027-06-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$17.84

per ml

Lowest NADAC/Unit

$6.78

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00003031505KENALOG-80 80 MG/ML VIAL	$17.84	ML	Brand	—	2026-08-19
00003029320KENALOG-40 200 MG/5 ML VIAL	$9.16	ML	Brand	$6.33	2026-08-19
00003029305KENALOG-40 40 MG/ML VIAL	$9.00	ML	Brand	$6.99	2026-08-19
00003029328KENALOG-40 400 MG/10 ML VIAL	$6.78	ML	Brand	$4.87	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$6.92

Highest Price

$85.95

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00003-0293-05KENALOG-40	$6.92	Big4	Bristol-Myers Squibb Company	04/30/2029
00003-0293-05KENALOG-40	$8.46	FSS	Bristol-Myers Squibb Company	04/30/2029
00003-0293-20KENALOG-40 INJ	$35.16	Big4	Bristol-Myers Squibb Company	04/30/2029
00003-0293-20KENALOG-40 INJ	$42.97	FSS	Bristol-Myers Squibb Company	04/30/2029
00003-0293-28KENALOG-40	$52.39	Big4	Bristol-Myers Squibb Company	04/30/2029
00003-0293-28KENALOG-40	$64.18	FSS	Bristol-Myers Squibb Company	04/30/2029

Showing 6 of 10 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Kenalog-40 (2024)

Total Spending

$18K

Total Claims

867

Beneficiaries

685

Avg Cost/Unit

$1.87

Spending Trend

$154K(2019)→$64K(2020)→$41K(2021)→$35K(2022)→$26K(2023)→$18K(2024)

YoY Change:+79.9%

5yr CAGR:+7.5%

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

API Supply Chain12 active DMFs15 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

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
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