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Last Updated: August 7, 2020

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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, Akorn, Bel Mar, Cent Pharms, Watson Labs, Pfizer, Eyevance, Novartis, Allergan, Taro, Alcon, Pharmafair, 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 twelve patent family members in ten countries.

There are eighty-eight 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
Midwest Eye InstitutePhase 4
Ocular TherapeutixPhase 4
New England Retina AssociatesPhase 4

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
Allergan PRED FORTE prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 017011-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Alcon ISOPTO CETAPRED prednisolone acetate; sulfacetamide sodium SUSPENSION;OPHTHALMIC 087547-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmafair PREDSULFAIR II prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088837-001 Dec 24, 1985 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Taro FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067-002 Jan 17, 2008   Start Trial   Start Trial
Taro FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067-001 Jan 17, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Mallinckrodt
Johnson and Johnson
Moodys
McKesson

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