Viewing data from:

XIPERE

NDA

TRIAMCINOLONE ACETONIDE | N211950 | BAUSCH AND LOMB INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Expiring < 1yr (1)Active (3)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

May. 2, 2027

Nov. 8, 2033

May. 2, 2034

Apr. 16, 2040

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 B Spending

CMS physician-administered drug spending for Xipere (2023)

Total Spending

$2.0M

Total Claims

1,345

Beneficiaries

914

ASP Price

—

HCPCS: J3299 — Injection, triamcinolone acetonide (xipere), 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

2 letters from Drugs@FDA

Date	Submission	Document
May 27, 2025	SUPPL -2	View Letter (PDF)
Oct 25, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

RLD

4 patents0 exclusivities▴

SUSPENSION;INJECTION | Approved: Oct 22, 2021

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8636713	May 2, 2027	—	—	—		—
9636332	Nov 8, 2033	—	—	—		—
9937075	May 2, 2034	—	—	Yes	—	—
12419833	Apr 16, 2040	—	—	Yes		—