PREDNISOLONE - Generic Drug Details

What are the generic sources for prednisolone and what is the scope of freedom to operate?

Prednisolone is the generic ingredient in thirty-eight branded drugs marketed by Schering, Chartwell Rx, Hikma, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, We Pharms, Muro, Teva, Halsey, Pharmacia And Upjohn, Ferndale Labs, Aurobindo Pharma Ltd, Barr, Bundy, Chartwell Molecular, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rising, Roxane, Sperti, Superpharm, Tablicaps, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Zhejiang Xianju, Pfizer, Bel Mar, Cent Pharms, Epic Pharma Llc, Harrow Eye, Sandoz, Abbvie, Lupin Ltd, Taro, Allergan, Alcon, Pharmafair, Novartis, Bausch And Lomb, Merck, Alcon Pharms Ltd, Sola Barnes Hind, Concordia Pharms Inc, Seton Pharm, Amneal, Amneal Pharms, Bausch, Edenbridge Pharms, Endo Operations, Mission Pharma, Vintage Pharms, Xttrium Labs Inc, and Genus, and is included in one hundred and twenty-six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighty-eight drug master file entries for prednisolone. Nine suppliers are listed for this compound.

Summary for PREDNISOLONE

US Patents:	1
Tradenames:	38
Applicants:	71
NDAs:	126
Drug Master File Entries:	88
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	770
Patent Applications:	7,093
Drug Prices:	Drug price trends for PREDNISOLONE
Drug Sales Revenues:	Drug sales revenues for PREDNISOLONE
What excipients (inactive ingredients) are in PREDNISOLONE?	PREDNISOLONE excipients list
DailyMed Link:	PREDNISOLONE at DailyMed

See drug prices for PREDNISOLONE

See drug sales revenues for PREDNISOLONE

Recent Clinical Trials for PREDNISOLONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sanofi	Phase 3
Post Graduate Institute of Medical Education and Research, Chandigarh	Phase 3
Kasr El Aini Hospital	N/A

See all PREDNISOLONE clinical trials

Pharmacology for PREDNISOLONE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for PREDNISOLONE

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XA	Corticosteroids, weak, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for PREDNISOLONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Edenbridge Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	203559-004	Feb 6, 2023	AA	RX	No	No
Abbvie	PRED MILD	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	017100-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Rising	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	202179-003	Apr 10, 2013		DISCN	No	No
Nesher Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	076988-001	May 24, 2005		DISCN	No	No
Muro	PRELONE	prednisolone	SYRUP;ORAL	089654-001	Jan 17, 1989		DISCN	No	No
Halsey	CORTALONE	prednisolone	TABLET;ORAL	080304-003	Approved Prior to Jan 1, 1982		DISCN	No	No

EU/EMA Drug Approvals for PREDNISOLONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
LE VET B.V.	Equisolon	Prednisolone	EMEA/V/C/002382 Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.	Authorised	no	no	no	2014-03-12