Viewing data from:

OMNIPRED

NDA

PREDNISOLONE ACETATE | N017469 | SANDOZ INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

394 trials from ClinicalTrials.gov — 40 recruiting, 25 active, 215 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy NCT02889523	Phase 1/2	Active	The Lymphoma Academic Research Organisation	214	2016-10 → 2029-09
TReatment for ImmUne Mediated PathopHysiology NCT04862221	Phase 2	Active	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	44	2022-02-09 → 2027-02
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma NCT04759586	Phase 3	Active	National Cancer Institute (NCI)	244	2021-10-05 → 2026-12-31
Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma NCT01920932	Phase 2	Active	St. Jude Children's Research Hospital	77	2013-08-12 → 2028-05
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 NCT03755804	Phase 2	Active	St. Jude Children's Research Hospital	232	2018-12-12 → 2028-07-01
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia NCT03007147	Phase 3	Active	Children's Oncology Group	352	2017-08-08 → 2027-08-14
Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents NCT03206671	Phase 3	Active	University Hospital Muenster	650	2017-08-03 → 2027-06
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)NCT06421935	Phase 1	Active	EMD Serono Research & Development Institute, Inc.	60	2024-08-07 → 2027-02-22
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer NCT05067140	Phase 1/2	Active	Novartis Pharmaceuticals	164	2021-09-02 → 2027-05-25
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia NCT03914625	Phase 3	Active	National Cancer Institute (NCI)	6,720	2019-07-03 → 2027-09-30

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 | 3 NDCs

Highest NADAC/Unit

$4.59

per ml

Lowest NADAC/Unit

$4.39

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61314063705PREDNISOLONE AC 1% EYE DROP	$4.59	ML	Generic	—	2026-08-19
61314063710PREDNISOLONE AC 1% EYE DROP	$4.45	ML	Generic	—	2026-08-19
61314063715PREDNISOLONE AC 1% EYE DROP	$4.39	ML	Generic	—	2026-08-19

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

API Supply Chain3 active DMFs2 inactive

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

EUROAPI FRANCEPREDNISOLONE ACETATE

DMF 35291979

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE ACETATE USP

DMF 285182014

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE ACETATE USP

DMF 327282018

DIOSYNTH BVInactivePREDNISOLONE ACETATE MICRO

DMF 39491980

PFIZER INCInactivePREDNISOLONE ACETATE USP,MICRO & NON MICRO

DMF 55041984

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2024	SUPPL -54	View Letter (PDF)
Mar 7, 2022	SUPPL -47	View Letter (PDF)
Oct 15, 2007	SUPPL -40	View Letter (PDF)
May 18, 2006	SUPPL -35	View Letter (PDF)
Jul 31, 2003	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLDAB

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.