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ARISTOCORT

NDA

TRIAMCINOLONE | N011161 | ASTELLAS PHARMA US INC

5 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articular Injection With a Suprascapular Nerve Block Versus a Glenohumeral Intra-articular Corticosteroid Injection in Retractile Capsulitis NCT07680504	Phase 2	Not Yet Recruiting	Nantes University Hospital	38	2026-06-25 → 2029-06-25

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

API Supply Chain0 active DMFs17 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ROUSSELL UCLAFInactiveTRIAMCINOLONE ACETATE AND TRIAMCINOLONE (ALCOHOL)

DMF 15501970

BRISTOL MYERS SQUIBB COInactiveTRIAMCINOLONE AND TRIAMCINOLONE ACETONIDE

DMF 16081970

PFIZER INCInactiveTRIAMCINOLONE

DMF 20351972

ANTIBIOTICOS SPAInactiveTRIAMCINOLONE

DMF 22061973

PIERREL SPAInactiveTRIAMCINOLONE ALCOHOL

DMF 26561976

BLASCHIM SPAInactiveTRIAMCINOLONE ALCOHOL

DMF 28521977

DIOSYNTH BVInactiveTRIAMCINOLONE MICRO

DMF 37591980

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

DMF 37951980

ROUSSELL UCLAFInactiveTRIAMCINOLONE

DMF 40811981

NITA PHARMACEUTICAL LTDInactiveTRIAMCINOLONE AND RELATED PRODUCTS

DMF 53531984

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveTRIAMCINOLONE

DMF 61051985

HOECHST MARION ROUSSEL SAInactiveTRIAMCINOLONE USP

DMF 62811986

QUATRUMInactiveTRIAMCINOLONE BASE

DMF 65531986

PFIZER INCInactiveTRIAMCINOLONE 21-ACETATE

DMF 67881987

HOECHST MARION ROUSSEL SAInactiveTRIAMCINOLONE 21-ACETATE

DMF 68481987

BRISTOL MYERS SQUIBB COInactiveTRIAMCINOLONE DIACETATE, STERILE

DMF 113491995

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveTRIAMCINOLONE 5 DRUG SUBSTANCE INTERMEDIATE

DMF 192912006

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