Prednisone

Sold as Meticorten, Deltasone, Paracort, Prednisone, Rayos. Every FDA application for this active ingredient: 5 branded and 118 generic.

As of Nov 14, 2026, FDA lists 123 applications for Prednisone (sold as Meticorten, Deltasone, Paracort and others), first approved Feb 21, 1955, with 0 new uses approved and 0 published complete response letters.

First approved: Feb 21, 1955
Applications: 123
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $67.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Prednisone	Part D	$63.1M	-3%	7,966,077
Rayos	Part D	$4.4M	-73%	428
PrednIsone	Part B	$252K	-31%	43,550
Prednisone Intensol	Part D	$170K	-3%	506

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PREDNISONE 1 MG TABLET: $0.040 per unitGeneric · -2% in a year
PREDNISONE 10 MG TAB DOSE PACK: $0.571 per unitGeneric · +4% in a year
PREDNISONE 10 MG TABLET: $0.052 per unitGeneric · -13% in a year
PREDNISONE 2.5 MG TABLET: $0.064 per unitGeneric · -18% in a year
PREDNISONE 20 MG TABLET: $0.065 per unitGeneric · -17% in a year
PREDNISONE 5 MG TAB DOSE PACK: $0.333 per unitGeneric · -15% in a year
PREDNISONE 5 MG TABLET: $0.037 per unitGeneric · -16% in a year
PREDNISONE 5 MG/5 ML SOLUTION: $0.518 per MLGeneric · -4% in a year
PREDNISONE 50 MG TABLET: $0.167 per unitGeneric · -20% in a year

Orphan Designations (FDA)

4 designations, 0 approved for the designated use; see all orphan designations

Treatment of Chronic Inflammatory Demyelinating PolyneuropathySarcomed AB · designated Mar 20, 2024
Treatment of Myasthenia GravisSarcomed AB · designated Mar 12, 2024
Treatment of Limb-Girdle Muscular DystrophySarcomed AB · designated Mar 5, 2024
Treatment of Duchenne Muscular DystrophySarcomed AB · designated Jul 13, 2022

Clinical Trials

602 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II StudyPlasmablastic Lymphoma · Institute of Hematology & Blood Diseases Hospital, China	Phase 2	Not yet recruiting	Nov 6, 2026
Venetoclax Plus Inotuzumab Reduced-Intensity Induction Sequentially Followed by Blinatumomab in B-ALLALL · Institute of Hematology & Blood Diseases Hospital, China	Not applicable	Not yet recruiting	Nov 6, 2026
Safety and Efficacy of Secukinumab Versus Mycophenolate Mofetil in Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (SMART)Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) · Chinese PLA General Hospital	Phase 3	Not yet recruiting	Nov 4, 2026
A Study to Evaluate Surovatamig Combined With R-CHOP in Participants of 18 to < 80 Years of Age With Previously Untreated Large B-cell Lymphoma With IPI Score 2 to 5Large B-cell Lymphoma · AstraZeneca	Phase 3	Not yet recruiting	Nov 2, 2026
MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)Metastatic Castration-resistant Prostate Cancer · Merck Sharp & Dohme LLC	Phase 1 / Phase 2	Not yet recruiting	Nov 2, 2026
Efficacy and Safety of Polatuzumab Vedotin, Rituximab Combined With Reduced-dose Cyclophosphamide, Doxorubicin and Prednisone Regimen in the Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma: A Multicenter, Single-arm, Prospective StudyDiffuse Large B-Cell Lymphoma · The First Hospital of Jilin University	Phase 4	Recruiting	Nov 2, 2026
Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate CancerProstate Cancer (Adenocarcinoma) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 2	Not yet recruiting	Oct 30, 2026
Molecular Evidence of Rejection Intervention TrialHeart Transplant Rejection · CareDx	Not applicable	Not yet recruiting	Oct 29, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 21, 1955	MeticortenNDA 9766 · New molecular entity	Schering	12	Discontinued
Jun 21, 1955	DeltasoneNDA 9986 · New formulation or manufacturer	Pharmacia And Upjohn	20	Discontinued
Dec 23, 1971	PrednisoneANDA 80279	Inwood Labs	0	Discontinued
Jan 17, 1972	PrednisoneANDA 80356	Watson Labs	24	Marketed
Apr 17, 1972	Delta-DomeANDA 80293	Bayer Pharms	0	Discontinued
Apr 21, 1972	PrednisoneANDA 80352	Hikma	22	Marketed
Apr 21, 1972	PrednisoneANDA 80563	Ferrante	0	Discontinued
Jul 5, 1972	PrednisoneANDA 80209	Contract Pharmacal	4	Discontinued
Jul 13, 1972	PrednisoneANDA 80328	Inwood Labs	0	Discontinued
Jul 13, 1972	PrednisoneANDA 80336	Aiping Pharm Inc	17	Discontinued
Nov 14, 1972	PrednisoneANDA 80701	Mutual Pharm	12	Discontinued
Jun 20, 1973	PrednisoneANDA 80343	Whiteworth Town Plsn	2	Discontinued
Jan 29, 1974	OrasoneANDA 83009	Solvay	0	Discontinued
Feb 26, 1974	PrednisoneANDA 83677	Mylan	35	Marketed
Mar 6, 1974	PrednisoneANDA 84133	Ivax Sub Teva Pharms	0	Discontinued
Mar 6, 1974	PrednisoneANDA 84134	Ivax Sub Teva Pharms	0	Discontinued
Mar 21, 1974	PrednisoneANDA 80320	Heather	0	Discontinued
May 2, 1974	PrednisoneANDA 80514	Chartwell Molecular	2	Discontinued
Jun 27, 1974	PrednisoneANDA 84275	Chartwell Molecular	3	Marketed
Jun 28, 1974	PrednisoneNDA 17109 · New formulation or manufacturer	Roxane	4	Discontinued
Dec 11, 1974	PrednisoneANDA 84417	Heather	0	Discontinued
Feb 25, 1975	PrednisoneANDA 84440	Everylife	0	Discontinued
Oct 21, 1975	PrednisoneANDA 84634	Mutual Pharm	14	Discontinued
Dec 9, 1975	Prednicen-MANDA 84655	Schwarz Pharma	5	Discontinued
Jun 23, 1976	PrednisoneANDA 85084	Watson Labs	20	Discontinued
Aug 26, 1976	PrednisoneANDA 85151	Pvt Form	5	Discontinued
Nov 11, 1976	PrednisoneANDA 85161	Watson Labs	19	Marketed
Nov 12, 1976	PrednisoneANDA 85162	Watson Labs	20	Marketed
May 31, 1978	PrednisoneANDA 85813	Rising	20	Discontinued
Jul 17, 1978	PrednisoneANDA 84913	Whiteworth Town Plsn	4	Discontinued
Apr 10, 1979	PrednisoneANDA 86596	Sun Pharm Industries	11	Discontinued
Apr 10, 1979	PrednisoneANDA 86595	Mutual Pharm	14	Discontinued
Jun 1, 1979	PrednisoneANDA 86813	Watson Labs	14	Discontinued
Oct 9, 1980	PrednisoneANDA 86867	Watson Labs	1	Discontinued
Jan 15, 1982	PrednisoneANDA 87682	Vangard	0	Discontinued
Jan 15, 1982	PrednisoneANDA 87701	Vangard	0	Discontinued
Mar 17, 1982	Liquid PredANDA 87611	Muro	2	Discontinued
Jul 13, 1982	PrednisoneANDA 87772	Watson Labs	12	Discontinued
Jul 13, 1982	PrednisoneANDA 87773	Watson Labs	12	Discontinued
Oct 4, 1983	PrednisoneANDA 88394	Duramed Pharms Barr	2	Discontinued
Oct 4, 1983	PrednisoneANDA 88395	Duramed Pharms Barr	2	Discontinued
Oct 4, 1983	PrednisoneANDA 88396	Duramed Pharms Barr	2	Discontinued
Jun 1, 1984	PrednisoneANDA 88465	Hikma Pharms	5	Discontinued
Oct 25, 1984	PrednisoneANDA 88866	Superpharm	1	Discontinued
Oct 25, 1984	PrednisoneANDA 88867	Superpharm	1	Discontinued
Oct 25, 1984	PrednisoneANDA 88865	Superpharm	1	Discontinued
Nov 8, 1984	PrednisoneANDA 88703	Hikma	22	Marketed
Feb 20, 1985	Prednisone IntensolANDA 88810	Hikma	18	Marketed
Dec 4, 1985	PrednisoneANDA 89247	Sun Pharm Industries	20	Marketed
Jul 24, 1986	PrednisoneANDA 89028	Whiteworth Town Plsn	0	Discontinued
Aug 2, 1988	PrednisoneANDA 89726	Xttrium Labs Inc	3	Discontinued
Jan 12, 1989	PrednisoneANDA 89983	Rising	4	Discontinued
Jan 12, 1989	PrednisoneANDA 89984	Rising	5	Discontinued
Sep 16, 1994	PrednisoneANDA 84774	Rising	0	Discontinued
Aug 29, 2001	PrednisoneANDA 40362	Jubilant Cadista	5	Marketed
Jul 12, 2002	PrednisoneANDA 40256	Ph Health	5	Marketed
Feb 12, 2003	PrednisoneANDA 40392	Ph Health	3	Marketed
Jan 8, 2004	PrednisoneANDA 40538	Hikma Pharms	2	Discontinued
Dec 21, 2004	PrednisoneANDA 40581	Ph Health	4	Marketed
Dec 21, 2004	PrednisoneANDA 40584	Ph Health	4	Marketed
Jun 6, 2005	PrednisoneANDA 40611	Jubilant Cadista	1	Marketed
Nov 1, 2010	PrednisoneANDA 40890	Hikma Pharms	2	Discontinued
Jul 26, 2012	RayosNDA 202020 · New dosage form	Horizon	10	Discontinued
Apr 25, 2017	PrednisoneANDA 204867	Actavis Labs Fl Inc	0	Discontinued
Dec 4, 2018	PrednisoneANDA 210525	Quagen	1	Discontinued
Dec 28, 2018	PrednisoneANDA 211496	Quagen	1	Discontinued
Nov 15, 2019	PrednisoneANDA 211575	Novitium Pharma	1	Marketed
Jun 16, 2020	PrednisoneANDA 213385	Amneal	1	Marketed
Jun 24, 2020	PrednisoneANDA 213386	Amneal	1	Marketed
Sep 2, 2020	PrednisoneANDA 210785	Strides Pharma	1	Marketed
Feb 11, 2021	PrednisoneANDA 208412	Strides Pharma	1	Marketed
Jul 6, 2021	PrednisoneANDA 215246	Novitium Pharma	1	Marketed
Nov 16, 2021	PrednisoneANDA 215671	Aurobindo Pharma Ltd	1	Marketed
Mar 28, 2022	PrednisoneANDA 215672	Aurobindo Pharma Ltd	1	Marketed
Dec 5, 2023	PrednisoneANDA 212629	Pharmazone	3	Marketed
Oct 1, 2025	PrednisoneANDA 219477	Dr Reddys	0	Marketed
Jun 26, 2026	PrednisoneANDA 218035	Dr Reddys	0	Marketed
—	ParacortNDA 10962	Parke Davis	2	Discontinued
—	PrednisoneANDA 84341	Heather	0	Discontinued
—	FernisoneANDA 83364	Ferndale Labs	0	Discontinued
—	PrednisoneANDA 80334	Vitarine	0	Discontinued
—	PrednisoneANDA 80371	Scherer Labs	0	Discontinued
—	ServisoneANDA 80223	Lederle	0	Discontinued
—	PrednisoneANDA 80232	Rexall	0	Discontinued
—	PrednisoneANDA 80237	Valeant Pharm Intl	0	Discontinued
—	PrednisoneANDA 80283	Ivax Sub Teva Pharms	0	Discontinued
—	PrednisoneANDA 80300	Halsey	0	Discontinued
—	PrednisoneANDA 80301	Marshall Pharma	0	Discontinued
—	PrednisoneANDA 80306	Inwood Labs	0	Discontinued
—	PrednisoneANDA 80321	Phoenix Labs Ny	0	Discontinued
—	PrednisoneANDA 80350	Panray	0	Discontinued
—	PrednisoneANDA 80353	Purepac Pharm	0	Discontinued
—	PrednisoneANDA 80359	Sperti	0	Discontinued
—	PrednisoneANDA 80397	Teva	0	Discontinued
—	PrednisoneANDA 80491	Elkins Sinn	0	Discontinued
—	PrednisoneANDA 80506	Vitarine	0	Discontinued
—	PrednisoneANDA 80782	Impax Labs	0	Discontinued
—	PrednisoneANDA 83059	Chartwell Rx	1	Discontinued
—	PrednisoneANDA 83676	Bundy	0	Discontinued
—	PrednisoneANDA 83807	Phoenix Labs Ny	0	Discontinued
—	PrednisoneANDA 84236	Kv Pharm	0	Discontinued
—	PrednisoneANDA 84662	Pharmavite	0	Discontinued
—	PrednisoneANDA 85115	Nylos	0	Discontinued
—	PrednisoneANDA 85543	Heather	0	Discontinued
—	PrednisoneANDA 85811	Elkins Sinn	0	Discontinued
—	OrasoneANDA 85999	Solvay	0	Discontinued
—	PrednisoneANDA 86061	Purepac Pharm	0	Discontinued
—	PrednisoneANDA 86062	Purepac Pharm	0	Discontinued
—	PrednisoneANDA 86946	Heather	0	Discontinued
—	PrednisoneANDA 86968	Lederle	2	Discontinued
—	PrednisoneANDA 87470	Upsher Smith	0	Discontinued
—	PrednisoneANDA 87471	Upsher Smith	0	Discontinued
—	CortanANDA 87480	Halsey	0	Discontinued
—	PrednisoneANDA 87833	Roxane	0	Discontinued
—	PrednisoneANDA 87984	Udl	0	Discontinued
—	PrednisoneANDA 87985	Udl	0	Discontinued
—	PrednisoneANDA 87986	Udl	0	Discontinued
—	PrednisoneANDA 89387	Am Therap	0	Discontinued
—	PrednisoneANDA 89388	Am Therap	0	Discontinued
—	PrednisoneANDA 89389	Am Therap	0	Discontinued
—	PrednisoneANDA 89597	Amneal Pharms Ny	0	Discontinued
—	PrednisoneANDA 89598	Amneal Pharms Ny	0	Discontinued
—	PrednisoneANDA 89599	Amneal Pharms Ny	0	Discontinued

Show all 123

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA