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Last Updated: November 2, 2024

PREDNISOLONE ACETATE - Generic Drug Details


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

Prednisolone acetate is the generic ingredient in eighteen branded drugs marketed by Schering, Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, Pfizer, Harrow Eye, Sandoz, Abbvie, Lupin Ltd, Taro, Allergan, Alcon, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Prednisolone acetate has eleven patent family members in nine countries.

There are eighteen drug master file entries for prednisolone acetate. Nine suppliers are listed for this compound.

Drug Prices for PREDNISOLONE ACETATE

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Drug Sales Revenue Trends for PREDNISOLONE ACETATE

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Recent Clinical Trials for PREDNISOLONE ACETATE

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

SponsorPhase
Baoping XUPhase 4
Wyse EyecarePhase 4
SalvatPhase 3

See all PREDNISOLONE ACETATE clinical trials

Pharmacology for PREDNISOLONE ACETATE
Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE ACETATE
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 ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Harrow Eye ECONOPRED prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 017468-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie PRED FORTE prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 017011-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan BLEPHAMIDE prednisolone acetate; sulfacetamide sodium SUSPENSION;OPHTHALMIC 012813-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan BLEPHAMIDE S.O.P. prednisolone acetate; sulfacetamide sodium OINTMENT;OPHTHALMIC 087748-001 Dec 3, 1986 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

Expired US Patents for PREDNISOLONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taro FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067-001 Jan 17, 2008 ⤷  Sign Up ⤷  Sign Up
Taro FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067-002 Jan 17, 2008 ⤷  Sign Up ⤷  Sign Up
Taro FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067-001 Jan 17, 2008 ⤷  Sign Up ⤷  Sign Up
Taro FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067-002 Jan 17, 2008 ⤷  Sign Up ⤷  Sign Up
Taro FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067-002 Jan 17, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PREDNISOLONE ACETATE

Country Patent Number Title Estimated Expiration
South Africa 200800926 ORAL SUSPENSION OF PREDNISOLONE ACETATE ⤷  Sign Up
Japan 2013014634 ORAL SUSPENSION OF PREDNISOLONE ACETATE ⤷  Sign Up
New Zealand 566117 Oral suspension of prednisolone acetate ⤷  Sign Up
Japan 2009503097 ⤷  Sign Up
European Patent Office 2630951 Suspension orale d'acétate de prednisolone (Oral suspension of prednisolone acetate) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.