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Last Updated: November 21, 2024

PREDNISOLONE Drug Patent Profile

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Which patents cover Prednisolone, and when can generic versions of Prednisolone launch?

Prednisolone is a drug marketed by Chartwell Rx, Hikma, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, We Pharms, 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, Teva, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Zhejiang Xianju, Bel Mar, Cent Pharms, Epic Pharma Llc, Lupin Ltd, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Edenbridge Pharms, Endo Operations, Mission Pharma, Pharmobedient, and Vintage Pharms. and is included in eighty-seven NDAs.

The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.

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Summary for PREDNISOLONE

US Patents:	0
Applicants:	53
NDAs:	87
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	770
Patent Applications:	4,875
Drug Prices:	Drug price information for PREDNISOLONE
Drug Sales Revenues:	Drug sales revenues for PREDNISOLONE
DailyMed Link:	PREDNISOLONE at DailyMed

Drug patent expirations by year for PREDNISOLONE

Drug Prices 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sola Barnes Hind	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	084171-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PREDNISOLONE TEBUTATE	prednisolone tebutate	INJECTABLE;INJECTION	083362-001	Feb 17, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tablicaps	PREDNISOLONE	prednisolone	TABLET;ORAL	085170-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Phoenix Labs Ny	PREDNISOLONE	prednisolone	TABLET;ORAL	080322-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mission Pharma	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	091396-001	Sep 13, 2010	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PREDNISOLONE	prednisolone	TABLET;ORAL	085416-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	083654-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for PREDNISOLONE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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