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Last Updated: April 28, 2024

PREDNISOLONE - Generic Drug Details

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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, Pfizer, Bel Mar, Cent Pharms, Epic Pharma Llc, Harrow Eye, Sandoz, Abbvie, 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, Mission Pharma, Vintage, Vintage Pharms, and Xttrium Labs Inc, and is included in one hundred and twenty-four 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. Six suppliers are listed for this compound.

Summary for PREDNISOLONE

US Patents:	1
Tradenames:	38
Applicants:	68
NDAs:	124
Drug Master File Entries:	88
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	760
Patent Applications:	6,992
Formulation / Manufacturing:	see details
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

Drug Prices for PREDNISOLONE

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Drug Sales Revenue Trends for PREDNISOLONE

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Recent Clinical Trials for PREDNISOLONE

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

Sponsor	Phase
Maastricht University Medical Center	Phase 2
Erasmus Medical Center	Phase 2
Academisch Ziekenhuis Groningen	Phase 2

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

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
Hikma	PREDNISOLONE	prednisolone	SYRUP;ORAL	040401-001	Feb 27, 2003	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lannett Co Inc	PREDNISOLONE	prednisolone	SYRUP;ORAL	040775-001	Sep 21, 2007	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva	PREDNISOLONE	prednisolone	TABLET;ORAL	080398-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Edenbridge Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	203559-002	Dec 20, 2016	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva	PRELONE	prednisolone	SYRUP;ORAL	089081-001	Feb 4, 1986	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	BLEPHAMIDE	prednisolone acetate; sulfacetamide sodium	SUSPENSION;OPHTHALMIC	012813-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Superpharm	PREDNISOLONE	prednisolone	TABLET;ORAL	088892-001	Feb 26, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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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