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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

354 trials from ClinicalTrials.gov — 13 recruiting, 14 active, 213 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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	475	2017-08-08 → 2027-09-30
ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016 NCT03286634	Phase 2	Active	National Hospital Organization Nagoya Medical Center	60	2017-04-18 → 2033-03-31
Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy NCT00268476	Phase 2/3	Active	Medical Research Council	11,992	2005-07-08 → 2030-12
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 NCT03755804	Phase 2	Active	St. Jude Children's Research Hospital	232	2018-12-12 → 2028-07-01
Deflazacort Vs. Prednisolone in Acute-stage ABPA NCT04227483	Phase 2/3	Active	Post Graduate Institute of Medical Education and Research, Chandigarh	150	2020-01-15 → 2025-07
Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D NCT03920007	Phase 1/2	Active	Atsena Therapeutics Inc.	15	2019-09-12 → 2027-05-19
Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma NCT03117751	Phase 2/3	Active	St. Jude Children's Research Hospital	790	2017-03-29 → 2028-09-30
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
Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)NCT03407144	Phase 2	Active	Merck Sharp & Dohme LLC	340	2018-04-09 → 2026-11-06
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

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$4.58

per ml

Lowest NADAC/Unit

$3.93

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61314063705PREDNISOLONE AC 1% EYE DROP	$4.58	ML	Generic	—	2026-06-17
61314063710PREDNISOLONE AC 1% EYE DROP	$4.58	ML	Generic	—	2026-06-17
61314063715PREDNISOLONE AC 1% EYE DROP	$3.93	ML	Generic	—	2026-06-17

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 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.