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Details for Generic Name: prednisolone acetate

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Prednisolone acetate is the generic ingredient in eighteen branded drugs marketed by Schering, Akorn, Bel Mar, Cent Pharms, Watson Labs, Pfizer, Alcon, Allergan, Taro, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-four patent family members in fourteen countries.

There are seventy-nine drug master file entries for prednisolone acetate. Twelve suppliers are listed for this compound.

Summary for Generic Name: prednisolone acetate

Tradenames:18
Patents:5
Applicants:12
NDAs:27
Drug Master File Entries: see list79
Suppliers: see list12
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: prednisolone acetate

Clinical Trials for: prednisolone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
PREDNISOLONE ACETATE
prednisolone acetate
INJECTABLE;INJECTION085781-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Watson Labs
PREDNISOLONE ACETATE
prednisolone acetate
INJECTABLE;INJECTION083654-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Bel Mar
PREDNISOLONE ACETATE
prednisolone acetate
INJECTABLE;INJECTION083738-002Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Alcon
ECONOPRED
prednisolone acetate
SUSPENSION/DROPS;OPHTHALMIC017468-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-001Jan 17, 2008DISCNNo7,799,331<disabled>Y<disabled>
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International Patent Family for Ingredient: prednisolone acetate

Country Document Number Publication Date
Israel108366Nov 30, 1999
Germany69939792Dec 04, 2008
European Patent Office0614659Sep 14, 1994
Australia5762894Sep 15, 1994
Austria312598Dec 15, 2005
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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