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Last Updated: March 28, 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, Taro, Allergan, Alcon, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-seven 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. Seven 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

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
Pharmafair PREDSULFAIR II prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088837-001 Dec 24, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis VASOCIDIN prednisolone acetate; sulfacetamide sodium OINTMENT;OPHTHALMIC 088791-001 Oct 5, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc PREDAMIDE prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088059-001 Jul 29, 1983 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067-002 Jan 17, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

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

International Patents for prednisolone acetate

Country Patent Number Title Estimated Expiration
Canada 2616112 SUSPENSION ORALE D'ACETATE DE PREDNISOLONE (ORAL SUSPENSION OF PREDNISOLONE ACETATE) ⤷  Try a Trial
European Patent Office 1909798 SUSPENSION ORALE D'ACETATE DE PREDNISOLONE (ORAL SUSPENSION OF PREDNISOLONE ACETATE) ⤷  Try a Trial
Japan 2009503097 ⤷  Try a Trial
European Patent Office 2630951 Suspension orale d'acétate de prednisolone (Oral suspension of prednisolone acetate) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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